Process Development Engineer

They're looking for a Process Development Engineer who can take a product from development into manufacturingJob Title: Process Development Engineer (Medical Device / Pharma)Location: Ohio ( Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)Duration: 12+ Months ContractExperience: 5+Summary: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.Key Responsibilities* 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).Required Qualifications* 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.Preferred Qualifications* 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.