Process Development Engineer

Industry

Engineering

Advert ID

FOX_BBBH74785

Location

Brooklyn Park

Job Type

Permanent

Hours

Full-Time

Salary Range

USD75000.00-110000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Process Development Engineer | Direct Hire | $75-$110k Base + Bonus | Brooklyn Park, MN



The Process Development Engineer position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.



ESSENTIAL RESPONSIBILITIES





* Attends and arranges project meetings to discuss current and future design and development initiatives



* May serve as a primary contact with clients on projects of moderate complexity



* Assist with preparation of proposals and quotations for clients; interfaces needed to resolve questions in a timely manner



* Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets



* Provide guidance and direction to coworkers on areas of technical expertise



* Troubleshoot production processes as required



* Evaluate and select appropriate test methods for product requirements



* Responsible for the following project inputs:



oFeasibility builds, documentation, and testing,



oEquipment selection,process development and documentation,



oDevice Verification samples and testing,



oOperator training,



oProcess Failure Mode Effects Analysis,



oClinical builds,



oProcess Validation



* Involvement in the full design, development, and validation requirements of projects, including:



oProduct design and specification creation, including mechanical and electrical components, assemblies, and packaging,



oMaterials sourcing and device prototyping,



oDesign verification and validation activities, including data for regulatory submission,



oManufacturing transfer and support of existing product lines as applicable







Qualifications:



Bachelor's Degree: Engineering

1+ year as a Process Development Engineer

Regulated industry experience



**Must be local to the Twin Cities