Staff Process Development Engineer

Overview

Lead development, validation, and continuous improvement of medical device manufacturing processes.

Key Responsibilities

• process development
• process validation
• capa support
• doe/fmea
• tooling development
• dfm/dfa

Tasks

-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. -Author and execute IQ/OQ/PQ protocols in compliance with FDA, ISO 13485, and company quality system requirements. -Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure manufacturability and compliance with design intent. -Drive continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction. -Mentor junior engineers and technicians in best practices for process development and validation. -Serve as a subject matter expert (SME) for assigned process technologies (e.g., laser welding, extrusion, molding, bonding, assembly automation). -Develop process characterization and risk assessments (e.g., DOE, FMEA). -Lead cross-functional teams to deliver process development milestones within scope, schedule, and budget. -Create and maintain process documentation, including work instructions, equipment specifications, and validation reports. -Lead the development and validation of new manufacturing processes, tooling, and equipment for medical device products. -Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles during product development. -Support regulatory submissions by providing technical documentation and process validation summaries.

Requirements

• six sigma
• lean
• minitab
• iso 13485
• automation
• 8+ years

What You Bring

-Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering discipline. -Experience with automation, robotics, or high-volume production processes. -Proven experience with process validation (IQ/OQ/PQ), design controls, and statistical analysis (e.g., Minitab, JMP). -8+ years of experience in process development or manufacturing engineering within the medical device or regulated industry. -Certified Six Sigma Green/Black Belt or Lean Manufacturing certification. -Strong understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. -Excellent problem-solving, analytical, and communication skills. -Master’s degree in Engineering or related field.

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About Lumicity

-Headquartered in Los Angeles with offices in San Diego, Houston, Miami, and Chicago, the firm has scaled effectively through strategic expansion. -Specializes in recruiting for Engineering, Life Sciences, Technology, and Energy sectors, targeting high-growth industries like semiconductors, robotics, and medical devices. -Operates on contract and direct-hire models, offering contingent, retained, and executive search services to meet client needs. -Project highlights include staffing C-suite roles in oncology biotech startups, scaling digital-health engineering teams post-Series C, and sourcing cleared RF engineers for aerospace clients. -Consultants bring industry expertise and a 'human touch,' leveraging deep domain knowledge to fill niche technical roles.

Sector Specialisms