We're Hiring: Senior Process EngineerWe're actively seeking a qualified
Senior Process Engineer to support manufacturing process validation, equipment integration, and product transfers within a medical device manufacturing environment.
Key Responsibilities- Execute process validation activities, including running samples, collecting and analyzing data, and preparing validation reports.
- Set up and troubleshoot manufacturing equipment, tooling, fixtures, and assembly line processes.
- Collaborate with Quality, Operations, Engineering, Materials, and cross-functional teams to support production readiness and process improvements.
- Develop and review process qualification documentation, including PFMEAs, Control Plans, SOPs, and PPAPs.
- Analyze equipment performance, establish operating parameters, and conduct experimental testing and results analysis.
- Support product transfers and cost-improvement initiatives while ensuring compliance with GMP and safety requirements.
- Lead or independently review process review meetings and manage assigned project workstreams.
Qualifications- Bachelor's degree in Engineering or a related technical discipline.
- 4+ years of relevant engineering experience.
- Experience with process and equipment validation, PPAP, and manufacturing equipment integration and troubleshooting.
- Knowledge of statistical methods, process development, and continuous improvement methodologies, including Six Sigma.
- Strong problem-solving, project management, communication, and cross-functional collaboration skills.
- Medical device industry experience strongly preferred.
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