Overview
CooperSurgical is a leading fertility and women's health care company focused on helping women, babies, and families during the moments that matter most. As a division of CooperCompanies, our purpose is to enable patients to experience life’s special moments. Guided by our values of being dedicated, innovative, friendly, collaborative, and doing the right thing, we offer more than 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, and an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Role Summary
The Senior Electrical Engineer will be responsible for maintaining the compliance, marketability, manufacturability and profitability of CooperSurgical’s diverse medical device portfolio. This role ensures products meet current regulatory and industry standards, keeps the product line aligned with market trends, and manages engineering changes caused by component obsolescence.
Key Responsibilities
- Lead cross-functional teams including operations, supply chain, regulatory and quality to ensure timely completion of change control projects.
- Design and develop electrical systems and components, including electrical schematics, wiring diagrams, and PCB layouts for medical devices.
- Write, execute and report on design verification studies.
- Create and update Design Control Documentation, including Design Inputs, Outputs, and the Traceability Matrix.
- Conduct feasibility studies and provide technical support for new and existing products.
- Perform and document thorough root cause analyses of complaints, nonconformities and CAPAs for advanced electromechanical medical devices using a structured approach.
- Drive product compliance projects with applicable regulatory and industry standards such as IEC 60601, and maintain relationships with key partners like UL.
- Participate in design reviews and offer constructive feedback to improve designs.
- Stay current with industry trends and advances in electrical design for medical devices.
Experience
- Minimum of 4 years of experience in electrical design for medical devices.
- Experience in design for EMC and electrical safety in accordance with IEC 60601-1-2 and IEC 60601-1 respectively.
- Experience solving problems with complex electromechanical devices and implementing design changes.
Education
- Bachelor’s degree or higher in Electrical Engineering or a related field.
Qualifications, Knowledge, and Abilities
- Strong grounding in electrical engineering principles, including analog and digital circuits, power electronics, and control systems.
- Proficiency with electronic test and measurement equipment such as oscilloscopes, logic analyzers, and processor emulators/debuggers.
- Experience with PCB design software and simulation tools such as Altium Designer and MATLAB.
- Familiarity with product development processes, including design controls, risk management, and design verification and validation.
- Ability to prioritize effectively and manage multiple concurrent projects.
- Experience with regulatory standards such as IEC 60601, FDA 820.11, MDR and ISO 13485.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal abilities, including technical test protocol and report writing.
- Ability to work in a fast-paced, high-pressure environment and meet deadlines.
Work Environment and Travel
This is an on-site, full-time role. The position requires prolonged computer work and may involve travel up to 10 percent of the time.
Compensation and Benefits
Salary range: $93,000.00 to $129,000.00 per year. The benefits package includes 401(k) with matching, dental and health insurance, health savings account, life insurance, paid time off, parental leave, fertility benefits, referral program, tuition reimbursement, and vision insurance. CooperSurgical offers a comprehensive total compensation plan including a strong benefits program.
Location
Trumbull, CT 06611. This position is to be performed on-site.