Senior Process Engineer

Work location: Stafford, TX (on-site)

Scope

The Senior Process Engineer is a key individual contributor responsible for the development, optimization, validation, and sustainment of manufacturing processes supporting medical device products.

This role partners cross-functionally with Quality, Manufacturing, R&D, and Supply Chain to ensure robust, compliant, and cost-effective processes throughout the product lifecycle while meeting all applicable regulatory and quality standards.

Job Summary

CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Senior Manufacturing Engineering at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products.

The Senior Manufacturing Engineer plays a critical role in driving integration projects, implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement.

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.

Travel: may be required to attend meetings or visit manufacturing sites. Approximately less than 5%

Qualifications

Knowledge, Skills and Abilities

• In-depth knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP

Work Environment

• Occasionally lift to 35 pounds.
• Production / Clean Room / Warehouse / Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.

Experience

• 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

Education

• Bachelor's degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or related field) required; Advanced degree preferred.
• Must have strong knowledge in:
• Process validation (IQ/OQ/PQ)
• Ideally both in transferring/scaling up existing processes as well as developing new processes

Our Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

• To all agencies: Please, no phone calls or emails to any employee of Cooper
• Surgical about this opening.
• All resumes submitted by search firms/employment agencies to any employee at Cooper
• Surgical via-email, the internet or in any form and/or method will be deemed the sole property of Cooper
• Surgical, unless such search firms/employment agencies were engaged by Cooper
• Surgical for this position and a valid agreement with Cooper
• Surgical is in place.
• In the event a candidate who was submitted outside of the Cooper
• Surgical agency engagement process is hired, no fee or payment of any kind will be paid.