Senior Process Engineer

We're Hiring: Senior Process Engineer

We'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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