Senior Process Engineer

Responsibilities

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 data-driven 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 ramp-ups, line transfers, and scale-up 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 cost-reduction 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 cross-functional projects as assigned.

Qualifications

• 7+ years of progressively responsible experience in process engineering within a regulated manufacturing environment; medical device experience strongly preferred
• Strong understanding of FDA QSR, ISO 13485 and risk management principles
• Proven experience with root cause analysis and structured problem-solving methodologies
• Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or related field) required; Advanced degree preferred
• Ideal skills include: Process validation (IQ/OQ/PQ), transferring/scaling up existing processes, and developing new processes