Staff Process Development Engineer

Key Responsibilities:Lead the development and validation of new manufacturing processes, tooling, and equipment for medical device products.Drive continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction.Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles during product development.Develop process characterization and risk assessments (e.g., DOE, FMEA).Serve as a subject matter expert (SME) for assigned process technologies (e.g., laser welding, extrusion, molding, bonding, assembly automation).Mentor junior engineers and technicians in best practices for process development and validation.Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure manufacturability and compliance with design intent.Author and execute IQ/OQ/PQ protocols in compliance with FDA, ISO 13485, and company quality system requirements.Create and maintain process documentation, including work instructions, equipment specifications, and validation reports.Support regulatory submissions by providing technical documentation and process validation summaries.Lead cross-functional teams to deliver process development milestones within scope, schedule, and budget.Partner with suppliers and contract manufacturers to develop and transfer new manufacturing processes.Support root cause analysis and corrective/preventive actions (CAPA) for process-related issues.RequiredBachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering discipline.8+ years of experience in process development or manufacturing engineering within the medical device or regulated industry.Proven experience with process validation (IQ/OQ/PQ), design controls, and statistical analysis (e.g., Minitab, JMP).Strong understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.Excellent problem-solving, analytical, and communication skills.PreferredMaster’s degree in Engineering or related field.Experience with automation, robotics, or high-volume production processes.Certified Six Sigma Green/Black Belt or Lean Manufacturing certification.