senior process development engineer.

• Supplier Evaluation & Onboarding: Assess potential and new supplier candidates for technical capability, manufacturing robustness, and quality compliance; provide direct technical leadership for component industrialization and introduction.
• Component Specification & Qualification: Collaborate with Design Engineering on component selection and emerging technologies; generate test protocols, monitor validation runs, analyze reliability, and formally approve components for production use.
• Inspection Systems & Metrology: Develop, source, and validate inspection tools, fixtures, and metrology equipment; establish robust incoming inspection procedures and lead technical training for inspection personnel.
• Root Cause & Defect Analysis: Lead technical investigations for incoming material non-conformances, manufacturing yield issues, and field failures; formulate risk-based dispositions and partner with suppliers to implement robust Corrective and Preventive Actions (CAPA / SCAR).
• Design for Manufacturability (DFM): Review and critique early-stage design specifications, ensuring component manufacturability, critical parameter definition, and quality yield optimization.
• Leadership & Team Mentorship: Provide technical guidance and operational supervision to incoming inspection and technical support teams.

the experience.

• Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Materials, Industrial, Chemical, Biomedical, or related discipline).
• Minimum of 9 years of hands-on engineering experience, with a proven track record in Supplier Quality Engineering (SQE), Process Development, or Component Engineering within a highly regulated manufacturing environment (Medical Device, Automotive, Semiconductor, or Advanced Aerospace).
• Deep practical knowledge of supplier audits, engineering change control, Supplier Corrective Action Requests (SCAR), production part approval processes, material control, and risk management (ISO 13485 / ISO 9001 / IATF 16949 / 21 CFR Part 820 standards preferred).
• Proven expertise in data-driven root cause analysis (e.g., 8D, DMAIC, Fishbone, 5-Why) and statistical techniques (SPC, Gage R&R, Process Capability/CpK, Minitab).
• Exceptional negotiation and stakeholder management skills to influence external suppliers and drive accountability across cross-functional internal teams.