Senior Risk Management Engineer

About CooperSurgical

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

• Review and evaluate scientific and technical data for product safety and performance.
• Create and maintain product risk management files that align with regulatory standards, lead risk assessments for reported clinical issues, assess production or post-production trends to identify potential safety or performance issues, and participate in CAPA investigations or actions for medical device risk management, production safety, and implementation of risk control measures.
• Create, evaluate, and validate product-related test methods.
• 100% remote work permitted.

• Master’s degree in Industrial Management, Engineering, or related field of study, plus 8 years of experience in regulatory requirements and standards for the development, approval, release, and maintenance of medical device / in-vitro diagnostic device products (21 CFR 820, ISO 13485, EU-MDD/MDR/IVDR).
• 8 years of risk management experience in a medical device or pharmaceutical environment (ISO 14971).
• 5 years of experience with remediation to EU-MDR (EU 2017/745, EU-IVDR, EU 2017/746 requirements. 5 years of experience with CAPA, sCAPA, SCAR, NCMR, and root cause investigation.
• 3 years of experience with product development statistics including the design of experiments, hypothesis testing, analysis of variance, design verification and validation testing, process validation testing, and test method validation

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

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.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $120,328 - $171,034. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.