Senior Manufacturing Engineer

Industry

Engineering

Advert ID

FOX_BBBH54359

Location

Plymouth

Job Type

Permanent

Hours

Full-Time

Salary Range

Based on Experience

No. of Openings

1

Branch Information

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

ContactNumber

612-630-1200

Job Description

Manpower Engineering has partnered with a growing medical device company that is now hiring for a Senior Manufacturing Process Engineer to join their successful team.



You will work in an entrepreneurial and collaborative environment where innovation and creative thinking are highly valued. The company is focused on empowering employees, providing flexibility with accountability and plenty of opportunity for long-term career growth.







Summary:



The Sr. Manufacturing (Process) Engineer will design, develop, and implement manufacturing processes and equipment to support existing commercial products and products in development. Processes and equipment may be located within the organization or within contract manufacturer sites.







Responsibilities:



* Translate device design requirements into process and equipment and manufacturing requirements that meet Regulatory and Quality requirements

* Provide support and expertise to new and existing manufacturing processes, troubleshoot line issues

* Collaborate on device designs to ensure manufacturability and automated packaging solution

* Lead and collaborate FMEAs (process/design, respectively) to identify and reduce risk

* Develop, execute, and document equipment qualifications and process validations, including master validation plans/reports and IQ, OQ, PQ plans/reports

* Develop, implement, and support production documentation including manufacturing procedures, routers, and bill of materials (BOM)

* Provide engineering support to customers, equipment suppliers, and contract manufacturers

* Utilize tools including measurement system analysis (MSA), gage repeatability and reproducibility (GRR), design of experiments (DOE), statistical process control (SPC), and capability analysis to develop and control processes

* Support test method and inspection method development/validation used during design verification, process validation, and commercial manufacturing

* Utilize tools including value stream mapping, overall equipment effectiveness (OEE), and 5S to understand and improve quality, labor efficiency, throughput, and cycle time

* Develop project timelines, scope of work, and other project documents to ensure cross-functional/cross-company alignment and project success

* Provide project communication to team members, customers, contract manufacturers, and stakeholders

* Support product complaint investigations and reports

* Support CAPA/NCR/SCAR investigations and reports







Qualifications:



* Bachelor's degree in engineering

* 5+ years of experience in the medical device industry supporting manufacturing

* Experience with manufacturing process instructions and equipment specifications

* Ability to communicate internally and externally with team members, suppliers, customers, stakeholders, and regulatory agencies

* Knowledge of GMP, CFR, ISO, QSR and other regulations, standards, directives and guidance

* Experience with statistical tools, data analysis, and Six Sigma methodology

* Hands on experience with assembly (manual and automated) equipment

* Ability to solve problems, troubleshoot, and improve processes and equipment

* Ability to manage multiple projects and work independently or in cross-functional team environment

* Ability to travel up to 25% as needed (domestic & international)