Senior Process Engineer responsible for developing, optimizing, and validating manufacturing processes for medical device products at CooperSurgical. Drives manufacturing excellence, implements lean principles, and fosters a culture of continuous improvement.
Requirements
- Lead the design, development, and implementation of manufacturing processes for new and existing medical device products.
- Identify opportunities to improve process capability, efficiency, yield, and cost through dataâdriven analysis.
- Develop process flow diagrams, PFMEAs, control plans, and work instructions to support stable manufacturing operations.
- Serve as a technical expert and escalation point for complex manufacturing process issues.
- Investigate process deviations, nonconformances, and complaints; drive root cause analysis and implement effective corrective and preventive actions (CAPA).
- Support production rampâups, line transfers, and scaleâup activities.
- Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable global regulatory requirements.
- Ensure processes are compliant with design controls, risk management, and quality system procedures.
- Author and review validation protocols, reports, and technical documentation.
- Apply Lean, Six Sigma, or other continuous improvement methodologies to enhance process robustness.
- Support costâreduction initiatives without compromising quality or regulatory compliance.
- Establish and monitor key process metrics to drive performance improvements.
- Collaborate with R&D during design transfer to ensure manufacturability and scalability.
- Partner with Quality Engineering to ensure ongoing compliance and risk mitigation.
- Work closely with Manufacturing, Supply Chain, and external suppliers to support sustained performance.
- Mentor and provide technical guidance to junior engineers and technicians.
- Influence best practices and engineering standards across the organization.
- Lead technical aspects of crossâfunctional projects as assigned.
- Travel: may be required to attend meetings or visit manufacturing sites. Approximately less than 5%.
Benefits
- Comprehensive benefits package
- 401k Matching
- Generous Paid Time Off
