Senior Process Engineer

Job Description

Cooper Surgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of Cooper Companies, we’re driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at

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.

The Senior Manufacturing Engineer at Cooper Surgical 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. CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare.

• 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.

May be required to attend meetings or visit manufacturing sites. Approximately less than 5%.

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

• 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.

• 7+ years of progressively responsible experience in process engineering within a regulated manufacturing environment; medical…