Job DescriptionAbout CooperSurgicalCooperSurgical 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 theforefront 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.Responsibilities
- 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
- Hybrid work environment offered, 4/5 days in the office, or as required by the business.
#LI-DD1Qualifications
- 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.
- Bachelor's degree or higher in Electrical Engineering or related field
- Strong knowledge of electrical engineering principles, including analog and digital circuits, power electronics, and control systems.
- 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.
- 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.
- Skilled using electronic test and measurement equipment such as oscilloscopes, Logic Analyzers, and processor emulators/debuggers.
- Ability to prioritize effectively and work on concurrent projects.
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.