Process Development Engineer

They're looking for a Process Development Engineer who can take a product from development into manufacturing

Process Development Engineer (Medical Device / Pharma)

Ohio (Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)

12+ Months Contract

5+

We are seeking a Process Development Engineer with a strong background in Medical Devices, Pharmaceuticals, or Combination Products to support process development, validation, and manufacturing activities. The ideal candidate will have hands‑on experience in packaging and assembly processes, process optimization, and product development within a regulated environment. This role requires close collaboration with cross‑functional teams to ensure robust manufacturing processes that meet quality and regulatory requirements.

• Develop, optimize, and implement manufacturing processes for medical devices, pharmaceutical products, or combination products.
• Support packaging and assembly process development from concept through commercialization.
• Conduct Failure Mode and Effects Analysis (FMEA) to identify and mitigate process risks.
• Design and execute Design of Experiments (DOE) for process optimization and continuous improvement.
• Utilize Statistical Process Control (SPC) tools to monitor process performance and drive quality improvements.
• Support Design Control activities throughout the product development lifecycle.
• Plan and execute equipment and process validation activities, including IQ, OQ, and PQ protocols.
• Prepare and review validation protocols, reports, engineering documentation, and technical reports.
• Develop prototypes and support engineering builds for new product introductions.
• Perform verification and validation testing to ensure product and process compliance.
• Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams.
• Ensure compliance with FDA regulations, ISO 13485, 14971 standards, and Good Manufacturing Practices (GMP).

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or a related engineering discipline.
• Experience in the Medical Device, Pharmaceutical, or Combination Product industry.
• Hands‑on experience with packaging and assembly process development.

• Experience supporting new product introduction (NPI).
• Knowledge of Lean Manufacturing or Six Sigma methodologies.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 (or applicable Quality Management System regulations).
• Experience with risk management and product lifecycle documentation.