What are the responsibilities and job description for the Process Development Engineer position at Fusion Life Sciences Technologies LLC?
They're looking for a Process Development Engineer who can take a product from development into manufacturing
Job Title: Process Development Engineer (Medical Device / Pharma)
Location: Ohio ( Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)
Duration: 12 Months Contract
Experience: 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.