Senior Staff Design Quality Engineer
About The Position
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. Work location: Trumbull, CT or Livingston, NJ (on-site). The Senior Staff Design Quality Engineer (DQE) will be a senior technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. This position will provide advanced expertise in implementing and maintaining robust quality management systems, leading design control and risk management activities across multiple projects, executing and/or defining plans for executing strategic goals established by leadership, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions. This position operates as a recognized subject-matter expert and technical authority in one or more specified DQE domains, influencing quality practices across projects/programs and leading the execution of strategic initiatives in alignment with organizational quality objectives. The Senior Staff Design Quality Engineer will provide technical leadership to ensure the successful development of Cooper products and ongoing operational support. This individual will be expected to apply his/her knowledge of design controls, risk management, verification and validation principles and quality engineering techniques to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. The Senior Staff Design Quality Engineer provides expert guidance on scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams, and provides mentorship (including coaching, reviewing, training, delegating work) to peers, leads and less experienced DQEs, and cross-functional engineering teams.
Requirements
- Senior technical individual contributor role.
- Advanced expertise in implementing and maintaining robust quality management systems.
- Subject-matter expert and technical authority in one or more specified DQE domains.
- Knowledge of design controls, risk management, verification and validation principles and quality engineering techniques.
- Expert guidance on scientific and technical data as it pertains to product and product testing.
- Ability to lead teams to identify and solve complex product problems.
- Ability to partner cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams.
- Ability to provide mentorship (including coaching, reviewing, training, delegating work) to peers, leads and less experienced DQEs, and cross-functional engineering teams.
Responsibilities
- Ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle.
- Implementing and maintaining robust quality management systems.
- Leading design control and risk management activities across multiple projects.
- Executing and/or defining plans for executing strategic goals established by leadership.
- Collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.
- Providing technical leadership to ensure the successful development of Cooper products and ongoing operational support.
- Applying knowledge of design controls, risk management, verification and validation principles and quality engineering techniques.
- Ensuring safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
- Providing expert guidance on scientific and technical data as it pertains to product and product testing.
- Leading teams to identify and solve complex product problems.
- Partnering cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams.
- Providing mentorship (including coaching, reviewing, training, delegating work) to peers, leads and less experienced DQEs, and cross-functional engineering teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
