Job Title: Senior Process Engineer
Reports To: Director of Engineering / Operations
Job Type: Full-Time
Department: Engineering / Operations
About the Role
The Senior Process Engineer will lead the development, validation, optimization, and continuous improvement of manufacturing processes within a regulated medical device environment. This role partners with Engineering, Operations, Quality, R&D, and Supply Chain to improve process capability, yield, efficiency, product quality, and cost. The ideal candidate brings strong technical problem-solving skills, hands-on manufacturing experience, and knowledge of medical device quality requirements.
Key Responsibilities
- Lead process development, optimization, validation, and continuous improvement initiatives.
- Develop and execute process validation activities, including IQ, OQ, and PQ.
- Analyze manufacturing data to improve yield, cycle time, throughput, capability, and cost.
- Lead root-cause investigations, CAPA, nonconformance resolution, and corrective actions.
- Support NPI, design transfer, process transfer, and production scale-up.
- Develop and maintain process specifications, work instructions, validation documentation, and engineering reports.
- Support equipment qualification, tooling, automation, and manufacturing technology improvements.
- Apply Lean, Six Sigma, SPC, DOE, PFMEA, and other process improvement methodologies.
- Partner with Quality and Regulatory teams to maintain compliance with FDA and ISO requirements.
- Lead cross-functional engineering projects and provide technical guidance to manufacturing teams.
Qualifications
Required
- Bachelor's degree in Engineering, Manufacturing, Biomedical Engineering, or a related technical field.
- 5+ years of process or manufacturing engineering experience, preferably in medical devices or regulated manufacturing.
- Experience with process validation, manufacturing process development, and continuous improvement.
- Knowledge of FDA Quality System requirements and ISO 13485.
- Experience with root-cause analysis, CAPA, SPC, DOE, and process capability.
- Experience supporting NPI, design transfer, or manufacturing transfer.
- Strong analytical, communication, project management, and problem-solving skills.
- Proficiency with Microsoft Office.
Preferred
- Lean Six Sigma certification.
- Experience with medical device manufacturing, automation, or advanced manufacturing technologies.
- Experience with Minitab, JMP, or similar statistical software.
- Knowledge of PFMEA, control plans, DFM/DFA, and risk management.
- Experience with ERP, MES, or manufacturing systems.
What We Offer
- Competitive salary and performance incentives.
- Medical, dental, and vision benefits.
- Employer-sponsored retirement plan.
- Paid time off and company holidays.
- Professional development and career advancement opportunities.
- Collaborative environment focused on quality and continuous improvement.
Travel: Up to 15% as needed.
Thank you,
Kay Raguindin
Division Manager
Health Staffing Group
(954) 998-7664 (Direct Line)
Mon Thurs 9am 6pm EST
Fridays 9am 1pm EST
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