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. 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.
Job Summary:
Product Engineers are responsible for maintaining the compliance, marketability, manufacturability and profitability of the diverse portfolio of medical devices offered by CooperSurgical. This means ensuring the products meet and are tested to the latest regulatory and industry standards, keeping the product line up to date with the latest market trends, and handling engineering changes due to component obsolescence.
Essential Functions & Accountabilities:
- Drive cross-functional teams including operations, supply chain, regulatory and quality to ensure timely delivery 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, Traceability Matrix.
- Conduct feasibility studies and provide technical support for new products and existing products.
- Perform and document comprehensive root cause analysis of complaints/NCs/CAPAs for advanced electromechanical medical devices using a methodical approach.
- Drive product compliance projects with relevant regulatory and industry standards such as IEC 60601, also maintain the relationship with key partners such as UL.
- Participate in design reviews and provide constructive feedback to improve designs.
- Stay up-to-date with industry trends and advancements 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 in performing and successfully resolving problems with complex electromechanical devices and executing design changes.
Education:
- Bachelor's degree or higher in Electrical Engineering or related field
Qualifications, Knowledge, Skills and Abilities:
- Strong knowledge of electrical engineering principles, including analog and digital circuits, power electronics, and control systems.
- Skilled using electronic test and measurement equipment such as oscilloscopes, Logic Analyzers, and processor emulators/debuggers.
- Proficiency in PCB design software and simulation tools such as Altium Designer and MATLAB.
- Experience with product development processes, including design controls, risk management, and design verification and validation.
- Ability to prioritize effectively and work on concurrent projects.
- Experience working with regulatory standards such as IEC 60601, FDA 820.11, MDR and ISO 13485.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills including technical test protocol and report writing skills.
- Ability to work in a fast-paced high pressure environment and meet project deadlines.
Work Environment:
- This role will be fully on-site 5 days a week
- Prolonged work in front of a computer.
Travel:
- May be required to travel up to 10% of time.
Cooper’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
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.
Job Type: Full-time
Pay: $93,000.00 - $129,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
