Process Engineer | Direct Hire | Menomonie, WI | Injection Molding

Our client and leader in the design, development, and manufacturing of drug delivery, diagnostic, and MedTech devices. Our facility in Menomonie, WI is looking for an Injection Molding Process Engineer to provide support to manufacturing and engineering with the objective to develop new processes and improve existing processes to improve safety and productivity while protecting our customers from receiving unacceptable parts


What You Will Do In Your Role

* Provide mentorship and guidance to Mold Technicians and evaluate out of range processes
* Continuously improve existing processes using design of experiments and other methods to increase efficiencies
* Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
* Keep up to date on injection molding equipment and process technology
* Provide engineering team with information and analysis tools
* Attend design meetings as part of the AQP process and provide insight and expertise in regard to the tool design, capability and part handling
* Implement systems and procedures that assure compliance with Quality Standards
* Where applicable, perform pre-planning safety into work activities to improve performance
* Proactively identify safety concerns
* Comply with Environmental Management System program SOP's/WI, Policy & Program elements and encourages responsible use of resources
* Participate in continual improvement/innovation, corrective action, FMEA and internal/external customer satisfaction
* Oversee technical development of mold technicians to help facilitate timely completion of their Mold Tech Development program responsibilities.
* Ability to perform cavity pressure monitoring and train Mold Technicians to use RJG edarts

The Experience You Will Bring

Requirements:

* Bachelor's degree in an engineering discipline OR minimum of 3 years of injection molding experience
* Working knowledge in at least (1) of the following areas: injection molding machines, systematic molding, or decoupled processing

What Will Put You Ahead

* Experience with RJG eDart or similar technology

Position Responsibilities


* Conduct sampling, data collection, and field documentation duties in coordination with task and project managers, and on-site field staff.
* Operate air monitoring and sampling equipment. Develop staging and mobilization/scheduling plans, logistical plans and equipment inventories for field sampling events.
* Develop and maintain instrumentation QA/QC data sheets and field logs
* Prepare field journal entries. Maintain photo-documentation and compile field data for reporting purposes

Preferred Qualifications


* Must have a minimum of one (1) year of related work experience
* Flexibility to work 6 days / week (total 50 hours/week) some weekend work required.
* Excellent work ethic and team-player attitude
* Strong attention to detail, with proven ability to follow specific instructions
* An ability to effectively express his or herself orally and in writing to other project staff
* Basic computer skills; Microsoft Office applications
* Trade certification, Associates Degree(s) and/or Bachelor's Degree in Engineering or Science is a plus
* First Aid/CPR training completion is preferred
* 40 Hour HAZWOPER course completion is preferred; selected candidate will be required to complete 40 hour HAZWOPER training or 8-hour annual refresher class
* Proficiency in AutoCAD, and/or ArcGIS software suites is a plus

We are looking for a CAD drafter to provide drafting, design, and engineering technical support with minimal supervision for the coordination, fabrication, and installation of company products,

Job responsibilities include:


* Develop and maintain drawings for coordination, fabrication, and installation using proper drafting standards
* Check drawings for accuracy and help verify the accuracy of others
* Assist other team members in completing their assigned tasks
* Designing Skills / Communication
* AutoCAD, Inventor and any 3D software experience
* Support fabrication and build of prototypes and production for RF filters.
* Product documentations (form factors & 3D files) for customers
* Microsoft Word and Excel proficient
* Good verbal and written communication skills

Manufacturing Engineer | Direct Hire | New Richmond, WI | $70-$85k Base

* Support Manufacturing Automation Projects following the AQP and GAMP 5 practices
* Functions as a liaison with project engineering, manufacturing and the customer regarding the implementation of programs, both molding and secondary operations
* Provide technical support/solutions to manufacturing processes, manage to establish yield and throughput, and drive for cost reduction and optimal quality
* Coordinate engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements
* Support our customers on a regular basis to resolve issues
* Support communication between customer, sales, engineering functions, outside vendors, manufacturing and multi-divisional groups
* Maintain cost control and profitability through interaction with the accounting group, sales and our customers
* Implement technical solutions to meet customer, cost, quality, and delivery expectations
* Facilitate and support facility and manufacturing safety, environmental and ergonomics efforts
* Support and monitor project timelines

Qualifications:



BS: Engineering

* 1-5 years' as Manufacturing Engineer - NPI & Existing product
Validation of equipment- IQ OQ PQ
Specking out assembly processes
Automotive, Med Device or Food Industry Experience

Sr. Manufacturing Engineer | Direct Hire | New Richmond, WI | $85k + Base


What You Will Do In Your Role

* Lead Manufacturing Automation Projects following the AQP and GAMP 5 practices
* Functions as a liaison with project engineering, manufacturing, and the customer regarding the implementation of programs, both molding and secondary operations
* Provide technical support/solutions to manufacturing processes, manage to establish yield and throughput, and drive for cost reduction and optimal quality
* Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements
* Interface with customers on a regular basis to resolve issues
* Facilitate communication between customer, sales, engineering functions, outside vendors, manufacturing and multi-divisional groups
* Maintain cost control and profitability through interaction with the accounting group, sales and our customers
* Implement technical solutions to meet customer, cost, quality, and delivery expectations
* Facilitate and support facility and manufacturing safety, environmental and ergonomics efforts
* Create and monitor project timelines

Qualifications:

* BS: Engineering
Would be more of a lead role
Experience implementing Automated equipment
6+ years of Manufacturing Engineering experience
Automotive, Medical Device or Food Industry (Regulated exp)

Growing engineering consulting firm is looking for a Sr Electrical Engineer or Sr SCADA Engineer to add to their team in the San Diego area. Position comes with full benefits, bonus and great career growth opportunities! Travel is primarily local with up to 25% domestic travel potentially on an occasional project basis. Relocation is provided as needed.

Qualifications:

* BS degree in Electrical Engineering
* 7+ years' experience with SCADA automation and networking for utilities
* PE or EIT
* SEL, Siemens, Ethernet experience all desired

EHS Specialist will be responsible for identifying, implementing EHS programs, improving existing EHS programs and strengthening overall performance at Richmond based facilities. Position works to ensure compliance with National, Regional and Local regulations. Create and implement environmental, safety, health, and regulatory compliance programs that comply with OSHA, EPA, DOT regulatory requirements. Utilize metrics and data to drive continuous improvement and enable sites to achieve vision of zero injuries/incidents/non-compliance. Maintain records which are needed to demonstrate compliance with safety and environmental compliance. Work to proactively head off EHS issues and concerns. Interact with local, state, and federal authorities on regulatory matters to ensure that Afton meets all compliance obligations. Provide processes, procedures and instruction for Afton personnel that ensures compliance with local, state, and federal regulations governing environmental, safety, and health issues. Provide EHS support to review proposed projects or new activities to identify and mitigate risks. Ensure adequate and appropriate safety, environmental, and regulatory training for personnel. Develop training programs, and secure outside training as necessary, select/recommend sources for training aids and materials as needed. Assist in implementation, maintenance and continuous improvement of the EHS management system - to sustain certification and deliver performance. Emergency Response/First Aid experience. Ability to identify EHS hazards and assess risks associated with the hazards. (ie. JSA, risk assessment, PPE assessment, ergonomics, IH monitoring and sampling, Process Hazard Analysis experience). Demonstrates understanding of level of risk, identifies where there is the need for immediate action and to flag risks for management review. EHS Risk Control: Ability to prevent, eliminate, reduce or mitigate EHS risks through management systems and a hierarchy of controls. EHS Compliance & Conformance: Ability to identify, analyze, communicate and manage compliance and conformance.EHS Management Systems: Ability to design, operate and maintain processes that support execution of the Afton EHS policy and drive continuous improvement. (ISO-14001 and RC-14001 management systems standards). Stakeholder Engagement: The ability to maximize the effectiveness of EHS by building the relationship and partnering with internal and external stakeholders (such as non-EHS colleagues, emergency responders, regulators, contractors, suppliers). Analysis and Problem Solving - Solves difficult problems with effective solutions; asks good questions and questions all likely sources for answers; can solve complex problems and recognize complex patterns; utilizing all appropriate tools to reach a robust answer. Coaching - The ability to provide the structure, environment and support for teaching, training and development of individuals and teams to enable them to achieve specific personal or professional results or goals.

Bachelor's degree in Environmental Sciences, Industrial Hygiene or Industrial Safety. 3-10 years relevant work experience in an industrial setting or equivalent combination of education and experience. Demonstrated effective program and project management, strategic thinking and leadership skills. Experience in manufacturing, laboratory and/or R&D environments. RCRA

Administrative Assistant

Manpower has partnered with one of the top employers in the market for Administrative Assistant at $20/hour in Houston, TX. Are you ready to work for a company that is legendary, inspires you to be your best, and gives you something to work towards? Beyond a paycheck, you want a purpose, a team of collaboration, and a support system of tenured trainers and managers. You want to know that your work is valued. At Manpower, we understand and we're here to help. Don't wait, Apply TODAY.

Why you'll Love Working for Us?
* Get a chance to work for one of the most innovative and rewarding companies in the world.
* Benefits including: Health, Dental, and 401K options for the adult in you.
* FREE College and upskilling courses available.

What is the Job?

* Provide analysis and support for vendor invoice accounts
* Perform administrative duties including data entry.
* Work with vendors to repair and standardize account information.
* Work with teams to support late payment processing.
* Work on a variety of issues and exercises to streamline and improve business process associated with account management.

What do you Bring to the Job?
* May have some experience with SAP or Oracle is a plus
* Attend staff meetings as needed
* Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook

Interested?
Select APPLY NOW and Recruiter will reach out within 24 hours

Stop your job search and apply today. Come see why our clients rely on us and see why our associates love working with us. We love referrals so please share our job with friends and family to potentially earn more $$$ in Referral Bonuses. Feel free to contact at 414 269 3151, [email protected]

Also, check out Manpower's career platform with tools and resources to prepare you for today and tomorrow's jobs at www.manpower.com/mypath

ManpowerGroup recognizes the importance of providing an accessible and barrier-free environment. We are committed to creating a welcoming, fair and inclusive environment by offering equal opportunity to access our services. At ManpowerGroup, we are committed to providing accommodations, and will work with you to meet your
needs.

Our client has openings for Design Engineers who have medical device industry experience along with plastics injection molding. These are direct hire positions located in Hudson, WI.

Position Duties:

* Work within a cross functional team to design products for and with our customers
* Learn and understand the Design Development Process and tools and the interdependencies of the different functional areas.
* Operate primary CAD systems such as SolidWorks or Creo
* Generate product designs that meet product requirements
* Identify and analyze design risks using tools such as tolerance analysis, static or dynamic simulation or hand calculations.
* Develop appropriate design risk mitigations and test strategies
* Work with production facilities to understand and incorporate production intent design for manufacturing (component level) and design for assembly (assembly level) into the design.
* Develop appropriate assembly and test fixtures to aide in the manufacture and testing of the design,
* Integrate the electronic elements into the product design
* Develop appropriate drawings to detail product and assembly specifications in a manner compliant with ASME or other design standards
* Maintain a design journal that identifies product risk and tracks design changes throughout the Design Development Process.
* Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.
* Identify and assess Design Risk via a dFMEA

Position Qualifications:

* Bachelor of Science in Mechanical Design or Engineering
* Minimum 3 years of experience in plastic injection molding and product development
* Design experience with medical devices or similar products
* Design for Manufacturability experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, etc)
* Experience performing tolerance analysis and structural analysis
* Familiar with ISO 13485 and ISO 14971
* Ability to travel up to 10% to other locations

Responsible for all routine operations and expansion activities. Assists with production planning and scheduling. Troubleshoots process problems. Develops process improvements that result in lower cost and improves quality. Assures safety program, ISO-9000 compliance. Provide technical and process control support to plant operations, troubleshooting plants' problems and evaluate cost reduction, optimization, safety, environmental, capacity increase and quality ideas. Provide process design and scope development for capital project. Preparing operating instructions, P&ID's, equipment specifications and other engineering documents. Furnish general process control support to plant operations and for capital projects.

Responsibilities


* Develop safety procedures to be employed by workers operating equipment or working in close proximity to ongoing chemical reactions.
* Troubleshoot problems with chemical manufacturing processes.
* Evaluate chemical equipment and processes to identify ways to optimize performance or to ensure compliance with safety and environmental regulations.
* Conduct research to develop new and improved chemical manufacturing processes.
* Determine most effective arrangement of operations such as mixing and heat transfer.
* Prepare estimate of production costs and production progress reports for management.
* Direct activities of workers who operate or who are engaged in production of petrochemical products.
* Understand and assist with DCS programming.

Required:

* BS in Chemical Engineering
* Strong safety/environmental commitment
* Team player, good communication, interpersonal skills, and leadership abilities
* Able to organize, prioritize and handle multiple tasks simultaneously
* Excellent trouble shooting and problem-solving skills
* Strong technical knowledge of process engineering project, plant start up
* Be able to work independently and take ownership for assigned work
* Basic cost and economics knowledge
* Process control or DCS programming experience a plus
* Knowledge of regulatory practices and polices (PSM, DOT, EPA, TNRCC).

Quality Engineer | Direct Hire | Medford, WI | Salary: Open

Our client is seeking a Quality Engineer to support their commercial injection molding facility in Medford, Wisconsin. They are a contract manufacturing business, supporting multiple customers, products and manufacturing processes.


What You Will Do In Your Role

* Lead AQP process and develop product quality criteria during new product introduction.
* Initiate and manage customer/internal corrective actions using data based, structured, problem solving methodology.
* Support quality functions of day to day manufacturing operations.
* Acknowledgment and understanding of all customer General Quality Agreements, General Quality Requirements and standards, as set by each customer
* Responsible for being a communication liaison between the customer and manufacturing facility
* Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
* Implement systems and procedures that assure compliance with Quality Standards
* Development and implementation of statistical incoming and in-process sampling/control plans
* Travel to other facilities may be required to support business needs



Requirements:

* BS: Engineering
Experience adhering to regulations (ISO 9001, ISO 13485, FDA)
Previous Quality experience

THIS POSITION WILL NOT PROVIDE VISA SPONSORSHIP

The Sales Engineer is responsible for developing and pursuing all new sales inquiries and leads and for contacting and visiting existing customers on a regular basis in assigned territory. The Sales Engineer acts as a technical sales liaison between the customer and the firm and oversees corporate trade show and advertising campaigns in their region as appointed by the Director of Sales. This position involves up to 50% travel domestically and sometimes internationally. He/She should have excellent interpersonal skills and a knowledge of the converting equipment user market and the ability to develop and expand existing markets.

ESSENTIAL DUTIES:
Promotes the sale of proprietary equipment, replacement parts and services.

* Maintains regular contact with all existing customers in assigned territory and makes visits as warranted or necessary.
* Develops and pursues all new sales inquiries and leads for proprietary equipment and follows through on requests for information in a prompt and orderly manner, including immediate travel to customer site, if necessary.
* Prepares written proposals and quotations for customer inquiries and handles all correspondence pertaining to corporate proprietary equipment. This is to be achieved in a prompt and orderly manner.
* Maintains a proper organized follow-up system to ensure accurate and timely follow-up on sales inquiries and leads are attained in assigned territory.
* Utilizes Corporate Customer Contact Management Software (currently Hubspot) for keeping contact with customers available for others to access when appropriate.
* Prepares and circulates written itinerary at least 24 hours prior to departure of all sales related travel.
* Prepares timely written reports of sales trips and visitations of substance and of customer plant demonstration visits within one week of said visit.
* Assists Director of Sales on an annual basis in anticipation of sales target meeting anticipated sales forecast within assigned sales territory for upcoming fiscal year.
* Organizes, plans and operates exhibits at planned annual domestic and sometimes international trade shows in cooperation with the Director of Sales. This includes responsibility for stand set-up and tear-down.
* Meets on a regular basis with the Director of Sales to coordinate relevant sales and marketing activities.
* Meets on an as needed basis with the Engineering Manager and his/her designee to discuss potential modifications and/or new product development as an outcome of new relevant inquiries or sales leads.
* Meets with executives, production and engineering management staff in a formalized setting to review anticipated orders in assigned territory.
* Monitors and evaluates the activities and products of the competition.
* Cooperates with other sales staff, individuals and appointees of the corporation in their sales efforts.
* Handles initial sales inquiries or calls in territories outside of those assigned if other sales staff are not available.

EDUCATION/JOB EXPERIENCE:
Associates related technical degree required. Bachelor's degree preferred. A minimum of three years prior automation or machinery sales experience in a manufacturing environment preferred. Valid Driver's License

The Sr. Controls Engineer is responsible for creating control systems for proprietary and special design machinery in response to specific assignments and requests. He/She should have demonstrated electrical design skills, writing skills and an understanding of mechanical machine design.


* Creates electrical control systems and drawings to applicable standards for machinery in response to customer specifications. The majority of this work will be performed on PC and CAD. Uses state-of-the-art programmable logic controllers and servo drives.
* Prepares machine or process concept sketches. Creates drawings, schematics, timing and sequencing diagrams and design calculations to support concepts and processes. Writes code necessary for the PLC and motion control systems. Some mechanical design work will be required.
* Assists in the preparation of machinery development cost estimates. Produces conceptual diagrams and calculations to support estimates.
* Limited travel to customer locations for consultation with customer prior to machine sale or for installation, start-up, training or servicing of machines. Limited travel to vendor locations for product evaluation or training.
* Prepares written literature for machine operation, maintenance and troubleshooting.
* Assists with start-up, troubleshooting and correction of new and existing machine designs on the shop assembly floor. Follows-up on machine field experience to improve machines and machine design.
* Leads each project to final completion.
* Evaluates and tests electrical components to determine proper selection relative to cost, machine requirements and application.
* Prepares and checks electrical diagrams and documentation for ease of understanding and interpretation by customer and in-house employees.
* Participates in continuous improvement initiatives including but not limited to Lean.
* Other duties and responsibilities may be assigned at the discretion of the Engineering Manager.

* Associate degree in Electrical Engineering or equivalent preferred.
* A minimum of 5 years prior electrical design experience preferred.

Demonstrated electrical design skills.


* Excellent written and verbal skills.
* An understanding of mechanical machine design a plus.

Overview

As a Civil Engineering Project Manager, with an emphasis on utility infrastructure design, your role will serve two objectives: 1) to establish the company as a provider of utility design services to local utilities, and 2) to support civil engineering department projects (in Knoxville and other offices) that have a significant utility design element. You will work with our commercial, institutional, and residential clients. From an urban redevelopment site, industrial sites, a new school project, to a new water distribution system or wastewater collection system for a local municipality, you'll take part in managing projects, quality control, client interfacing, budgeting, and mentoring and supervising junior engineers. Interacting with clients, contractors, local government officials, you'll impact the whole project - from conceptual and design phases, through the regulatory review process, bidding, and construction, all the way completion.

Qualifications


* Minimum of 5+ years' experience
* BS in Civil Engineering, with emphasis on water and sewer utility design;
* Professional Engineering License (P.E.) required
* Ability to speak and write professionally;
* Ability to develop and mentor staff;
* Ability to provide a technical review of Civil Engineering/Utility deliverables;
* Ability to prepare proposals and manage project execution;
* Ability to interface with clients, network, and develop business.

Day shift temp to perm *Perform complex and advanced assembly of aircraft components according to engineering drawings, established specifications and instructions by installing solid shank rivets. Read and interpret blueprints, illustrations, and specifications to determine layouts, sequences of operations, or identities and relationships of parts.Monitor the functioning of all equipment and report any problems or substandard condition to the supervisor.Ensure all documents are maintained according to standard operating procedures. Perform final checks and adjustments for any defects to ensure high quality products. Trade School preferred Aerospace background

Senior Regional Operations Project Manager - Manufacturing - Direct Hire!

Are you a skilled, hands-on Manufacturing Operations Professional with proven experience and success in leading projects? Are you interested in joining a growing, collaborative, fast paced organization who has an emphasis on serving internal (employees) and external customers? Are you looking for an opportunity to where you can have/make a direct impact, make the role your own, while having visibility throughout an entire business including at the executive level? If so, please keep reading....

Position Overview:
You will be responsible for leading multiple region-wide projects from conceptualization to implementation for a leading global engineering components & systems manufacturer headquartered in Southeastern Wisconsin with locations throughout North America, South America, Asia Pacific, and Europe. The nature of the projects will vary in terms of size & scope, but will be manufacturing operations focused (facility footprints, facility relocations, equipment moves).

Key Functions & Responsibilities Will Include:

* Provide support, technical expertise and leadership in the area of Project Management
* Will use established project management methodologies to lead multiple region-wide projects from conceptualization to implementation
* Develop and lead multiple concurrent regional improvement projects supporting business strategy including facility rationalization and growth initiatives
* Ownership of delivering project on-time and on-budget by utilizing established project management tools and leadership, including identification and management of overall project objectives, dependencies, project risks, critical paths, mitigations plans where necessary with project team members and key stakeholders
* Prepare communication plan, project reports, and conduct key stakeholder meetings to provide updates on activities and deliverables, as well as significant changes, risks and mitigation strategies. Identify and escalate issues to ensure resolution
* Appropriately identify risk and resolve negative consequence to timeline and budget.
* Act as a functional expert for operations and/or supply chain on project teams as required
* Participate and contribute to the on-going development and implementation of project management best practices and processes

Requirements and Desired Qualifications:

* Bachelor's Degree in Engineering or related discipline required. Master's degree in Engineering, or an MBA is preferred
* At least 10 years relevant experience demonstrating strong results in areas of Plant Operations, Facility Relocations, and Project Management
* Results-oriented approach with a track record of success in a fast-paced, multi-site, global environment
* Excellent communication skills (written and verbal) with experience with experience presenting information to various levels of an organization.
* Lean tools understanding, development and implementation
* Strategic view and problem solving expertise
* Experience working with international projects and individuals is preferred
* Project Management Professional (PMP), or related certification preferred
* Ability to travel 50-75% regionally, including outside the United States without restriction

A client of ours is seeking an Entry Level Product Development Engineer with MEDICAL DEVICE internship experience to join their team and work along the development process anywhere from concept and ideation through commercialization. Candidates with experience within the catheter space are highly sought after. This is a direct hire opening located in Maple Grove, MN. Seeking candidates LOCAL TO MN!

Duties and Responsibilities


* Leads development of concepts, prototypes, processes, and products from initial design to market release
* Assists in writing proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts
* Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation
* Maintains detailed documentation throughout all phases of research and development
* Ability to generate and execute protocols and reports as needed to support validation activities, including Design Verification, IQ, OQ, PQ


Position Qualifications:


* Bachelor's degree in Mechanical, or Biomedical Engineering is prefererd
* Seeking entry level to 3 years of experience within medical device design and development
* Entry level candidates MUST have had a medical device internship to be considered
* Familiarity with FDA QSR and ISO 13485 medical device regulations
* SolidWorks 3D CAD proficiency
* Familiarity with design for catheters and extrusions is highly preferred but not required

** Visa sponsorships are NOT available

The primary result expected from the Process Engineer is to control internal processes to manufacture products by defining and analyzing the manufacturing process of both milling and filling operations for improvement in quality, safety, and efficiency, and creating, improving, and maintaining manufacturing Process Instructions (PI) and salvage/rework integration.

Typical tasks for this position include (but are not limited to) the following:



* Develop safety procedures to be employed by workers operating equipment or working in close proximity to on-going chemical reactions.
* Troubleshoot problems with chemical manufacturing processes.
* Evaluate chemical equipment and processes to identify ways to optimize performance or to ensure compliance with safety and environmental regulations.
* Conduct research to develop new and improved chemical manufacturing processes.
* Determine most effective arrangement of operations such as mixing, crushing, heat transfer, distillation, and drying.
* Perform tests and monitor performance of processes throughout stages of production to determine degree of control over variables such as temperature, density, specific gravity, and pressure.
* Design and plan layout of equipment.
* Prepare estimate of production costs and production progress reports for management.
* Design measurement and control systems for chemical plants based on data collected in laboratory experiments and in pilot plant operations.
* Develop processes to separate components of liquids or gases or generate electrical currents using controlled chemical processes.

Required



* Degree in Mechanical Engineering or Chemical Engineering with hands-on chemical experience.
* Good process management, written and verbal communication skills are required along with a high level of initiative.
* Demonstrated strong leadership skills, in project and people management in a continuous improvement environment in the areas of production, safety, quality and Lean manufacturing principles.

Responsibility for developing, auditing, and accepting a wide range of engineering deliverables generated by the project contractor. The Process Engineer will be accountable for managing the P&ID development and the management of change process. . Works with existing technology, engineering contractor, and project personnel to assure accuracy and efficiency in vendor/equipment selection. Helps define and clarify technical requirements and specifications to the procurement team, vendors, and construction personnel. This position will institute best engineering practices, challenge cost, and assure operational reliability in a cost driven project environment. The Process Engineer will also work with the Operations/Maintenance Representative to develop the project commissioning and startup strategy and assists the engineering contractor in development of the DCS and packaged unit controls for the plant. This position will also fully support the handover, pre-commissioning, commissioning, and start-up of the facility.


Requirements:

* Bachelor Degree in Chemical or Process Engineering required.
* Minimum of five (5) years of engineering/project experience required.
* Grass-roots, greenfield, start-up experience highly preferred
* Background in the production of polymers highly preferred
* Working knowledge of process specification of instruments, heat exchangers, control valves, pumps, compressors, filters, mixers and other key equipment
* Knowledge of layers of protection analysis (LOPA) and HAZOP standards

Product Development Technician OR Manufacturing Technician | Direct Hire | Up to $63k yearly | Maple Grove, MN | Medical Device Industry

DUTIES:

* Design, prototype, and test components and sub-assemblies to meet product objectives, including tooling, test stations and fixtures.
* Contribute to the design and development of new minimally invasive and orthopedic products, under the direction of R&D engineers.
* Assist in writing procedures, specifications, and reports.
* Utilize established mathematical and scientific techniques to compile and analyze data with common analytical software such as Excel or Distribution Analyzer.
* Apply both technical intuition and analytical rigor and constructively provide critical technical assessment of their own and other's work.
* Cross-train other team members when required.
* Perform duties in accordance with established procedures, including good documentation practices.
* Interact with internal teams to explore, troubleshoot and improve designs, fabrication processes and procedures.
* Create 3D models of products, components, and tools, as needed.
* Print prototypes and tools on 3D printer.
* Performs other duties as needed.
Quality Systems
* Perform various quality assurance tasks such as review of quality records, including lot history records, and returned product records.
* Create and update quality system documents such as systems procedures in accordance with ISO 13485:2016 and FDA regulations.
* Maintenance of quality system records and files as required.
* Assist or perform investigations such as CAPA or Nonconformance investigations.
* Perform review of quality records to ensure GDP requirements are met.
Quality Inspection Support
* Performs visual and dimensional inspections and evaluations of components and devices according to product specifications.
* Complete First Article Inspections and supporting documentation
* Maintain accurate and up to date records of all materials. These activities are conducted during incoming receiving, in-line inspections, returned materials, etc.
* Assist in the development and improvement of product assurance systems such as incoming and in-process quality control, statistical process control, nonconformity controls, product lot release testing, and finished goods control.
Operations Support
* Assembles product in a production environment in the cleanroom and in the lab, as directed by his/her manager.
* Perform preventive equipment maintenance tasks as directed by operations.
* Perform other routine operations functions as directed by operations.
* Perform weekly Product Processing Area cleaning as well as keeping daily lab tidiness and cleanliness.
* Assist in managing the inventory control system.
* Assist in performing receiving activities.
* Creates and performs calibration procedures for in-house calibration activities, as directed by engineering.

QUALIFICATIONS:

Med device, Sr. Operator or Tech or Associate Engineer level role
Balloon catheter/balloon bonding
Coil & braided shaft
liner stretching
Manual brake
Well versed in reinforced shaft (PET Heat Shrink)