The process engineer will manage the development and transfer of manufacturing processes for medical devices and drug device combination products at an external manufacturing site. Job duties will include but are not limited to the following: The candidate should be proficient in the following general areas –
• Medical device development per 21CFR820.30 and ISO 13485.
• Management of contract manufacturing organizations.
• Collaboration with internal and external suppliers at a detailed technical level with design engineers, equipment, and production engineers
. • Review of technical reports including statistical analysis of data.
• Equipment procurement and qualification including GAMP5.
• Risk management per ISO 14971.
• Process validation The candidate should have specific technical expertise in the following topics –
• Development of custom automation including process optimization.
• Development and procurement of packaging equipment for sterile barrier systems.
• Process FMEA and risk management.
• Clean room manufacturing operations.
• Semi-automated and automated vision system inspections (development and validation).
• Familiarity with injection molding and micro molding. Additionally, the candidate should have experience with the following –
• Internal quality assessments/audits, regulatory inspections, and notified body interactions.
• Discrepancy and change management.
• Authoring documents to support device development: design verification protocols/reports, d/pFMEAs, risk management plans, design transfer plans, and change management plans. The candidate should possess the following interpersonal skills –
• Proven track record of working effectively in a matrix organization with a highly crossfunctional (e.g., validation, quality, regulatory, and program management) and collaborative environment.
• Excellent oral and written communication skills.
• Excellent leadership skills.
• Success in project planning, resource management, and liaising with engineering and manufacturing resources, potentially in other countries.
• B.S, M.S, or advanced degree in engineering, with preference for mechanical or chemical engineering, or the equivalent. • At least 10+ years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.