Manufacturing Engineer at Resource Logistics

Wayne State University; Plymouth (MN); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Wayne State University in Plymouth, MN seeks an experienced Manufacturing Engineer with a strong background in medical device manufacturing to support manufacturing engineering, NPI, and process development.

Ideal candidates have 5+ years of professional experience, hands-on IQ/OQ/PQ, and familiarity with regulated quality systems (FDA 21 CFR Part 820, ISO 13485, GMP/cGMP). This is a 100% onsite role in Plymouth.

Qualifications

• Must have 5+ years of professional Manufacturing Engineering experience.
• Experience with Class I, II, or III medical devices is strongly preferred.
• Hands-on IQ/OQ/PQ experience.
• NPI/NPD experience.
• Process development and validation experience.
• Test fixture/tooling design and development experience.
• DFM and manufacturing readiness knowledge.
• Cross-functional collaboration with R&D, QA and Operations.
• Test fixture and tooling design/development
• Manufacturing equipment development and qualification
• Design for Manufacturability (DFM)
• Manufacturing readiness and process scale-up
• Understanding of the product development lifecycle
• Cross-functional collaboration with R&D, Quality, Operations, and Engineering teams
• Experience working in regulated manufacturing environments

Responsibilities

• Develop and improve manufacturing processes for medical device products.
• Support NPI and new product transfer from development through commercialization.
• Develop, execute, and document IQ/OQ/PQ process and equipment validation.
• Perform process characterization and capability studies.
• Develop and validate manufacturing and inspection test methods.
• Design and improve test fixtures, tooling, and manufacturing equipment.
• Support DFM activities and provide manufacturing input during product development.
• Maintain manufacturing documentation, procedures, protocols, and reports.
• Troubleshoot manufacturing issues and implement corrective actions.
• Collaborate with global teams to ensure manufacturing readiness.
• Support continuous improvement and productivity initiatives.

Skills

5+ years of experience

NPI / NPD

IQ/OQ/PQ

Process development

Process validation

DFM

Tooling design

GMP/cGMP

Cross-functional collaboration

Regulated manufacturing

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Master's degree preferred

Job description

Location: Plymouth, MN
Work Arrangement: 100% Onsite
Contract: Contract
Experience Required: 5+ years

Position Overview

We are seeking an experienced Manufacturing Engineer with a strong background in medical device manufacturing to support manufacturing engineering, new product introduction, process development, process validation, tooling, and equipment development.

The ideal candidate will have hands‑on experience working in regulated medical device manufacturing environments and be comfortable collaborating with Engineering, Quality, R&D, Operations, and other cross‑functional teams

Required Experience

Must have 5+ years of professional Manufacturing Engineering experience.

Candidates should have hands‑on experience with several of the following:

5+ years of Manufacturing Engineering experience

Medical device manufacturing experience

New Product Introduction (NPI) / New Product Development

Manufacturing process development and optimization

Process characterization

Process validation, including IQ/OQ/PQ

Test method development and validation

Inspection method development and validation

Test fixture and tooling design/development

Manufacturing equipment development and qualification

Design for Manufacturability (DFM)

Manufacturing readiness and process scale-up

Understanding of the product development lifecycle

Cross-functional collaboration with R&D, Quality, Operations, and Engineering teams

Experience working in regulated manufacturing environments

Preferred Medical Device Experience

Experience with Class I, II, or III medical devices is strongly preferred.

Experience with regulated quality systems and standards such as:

FDA 21 CFR Part 820

ISO 13485

GMP/cGMP

Design controls

PFMEA/DFMEA

CAPA

Statistical process control

Education

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline required

Master's degree preferred

What You’ll Do

Develop and improve manufacturing processes for medical device products.

Support NPI and new product transfer activities from development through commercialization.

Develop, execute, and document IQ/OQ/PQ process and equipment validation.

Perform process characterization and capability studies.

Develop and validate manufacturing and inspection test methods.

Design and improve test fixtures, tooling, and manufacturing equipment.

Support DFM activities and provide manufacturing input during product development.

Develop and maintain manufacturing documentation, procedures, protocols, and reports.

Troubleshoot manufacturing and process issues and implement corrective actions.

Collaborate with cross-functional and global teams to ensure manufacturing readiness.

Support continuous improvement, process optimization, quality, and production efficiency initiatives.

Candidate Requirements

5+ years of Manufacturing Engineering experience

Medical device manufacturing experience strongly preferred

Hands‑on IQ/OQ/PQ experience

NPI/NPD experience

Process development and validation experience

Test fixture/tooling experience

Strong technical documentation and problem-solving skills

Bachelor's degree in Engineering

Ability to work 100% onsite in Plymouth, MN