Medical Device Manufacturing Engineer — Onsite Plymouth

Wayne State University; Plymouth (MN); Híbrido; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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.

Conocimientos

5+ years of experience

NPI / NPD

IQ/OQ/PQ

Process development

Process validation

DFM

Tooling design

GMP/cGMP

Cross-functional collaboration

Regulated manufacturing

Educación

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Master's degree preferred

Descripción del empleo

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.