Senior Process Engineer

CooperSurgical; Stafford (TX); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Senior Process Engineer in Stafford, Texas. The engineer will lead manufacturing process design and optimization for medical devices, ensuring compliance with regulatory standards. They will improve process efficiency and mentor junior staff. Candidates should have a strong engineering background and experience in a regulated environment.

Key responsibilities include implementing process validation, data-driven analysis, and collaboration with cross-functional teams. Excellent benefits including medical coverage, 401(k), and parental leave are offered.

Qualifications

• 7+ years of experience in process engineering within a regulated manufacturing environment.
• Strong understanding of FDA QSR, ISO 13485 and risk management principles.
• Proven experience with problem-solving methodologies.

Responsibilities

• Lead the design and implementation of manufacturing processes for medical devices.
• Identify opportunities to improve process capability and efficiency.
• Plan and execute process validation activities compliant with regulations.

Skills

Process validation (IQ/OQ/PQ)

Root cause analysis

Data-driven analysis

Education

Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical)

Job description

Job Description

CooperSurgical 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 CooperCompanies, 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 www.coopersurgical.com.

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

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

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
  
  
  
  

Benefits

As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan. You’ll get medical coverage, a 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.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.