Process Development Engineer

About the Role This role provides technical leadership in developing, validating, and transferring manufacturing processes from R&D to commercial production for medical devices. It ensures processes are robust, scalable, and compliant with regulatory requirements including FDA 21 CFR Part 820 and ISO 13485, with a track record of successful product introductions in a regulated environment. What You'll Do

• Lead the development, characterization, and optimization of manufacturing processes for new and existing products.
• Lead large-scale process validation strategies (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations; apply DFSS tools (DOE, SPC, capability analysis) to improve process performance and robustness.
• Manage design transfer activities from R&D to Manufacturing, ensuring readiness for commercial production. Partner with cross-functional teams to ensure designs are manufacturable, scalable, and cost-effective (DFM/DFA). Support product launches, including pilot builds and ramp-to-production activities. Ensure compliance with FDA, ISO 13485 and internal quality systems. Conduct and support risk management activities (FMEA, hazard analysis). Participate in audits and inspections, providing technical expertise and documentation support.
• Act as the primary technical interface in a cross-functional Core Team; collaborate with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity. Provide guidance and mentorship to junior engineers and technicians.
• Identify and drive process improvement initiatives using Lean and Six Sigma methodologies. Monitor and analyze process performance metrics to improve yield, reduce scrap, and increase efficiency. Support CAPA investigations and implement sustainable solutions. What We're Looking For
• Master’s degree (preferred) or bachelor’s degree in Mechanical, Biomedical Engineering or related technical field.
• Demonstrated technical leadership in process development, transfer to manufacturing, validation, and cross-functional collaboration in a regulated environment.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485; experience with FMEA, risk management, audits.
• Proficiency with DFSS tools (DOE, SPC) and statistical analysis; experience with process validation strategies (IQ/OQ/PQ). Compensation & Benefits
• Salary range: $115,000 - $135,000 per year.
• Remote Work: 1-2 days at home (site-based).