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CooperSurgical

Senior Design Quality Engineer

CooperSurgical, Livingston, New Jersey, us, 07039

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Job Description CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the moments that matter most in life. We are at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. CooperSurgical, a wholly‑owned subsidiary of CooperCompanies (Nasdaq: COO) 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”.

In this role you will be part of an experienced R&D engineering team that leads, designs, and tests medical device products developed on site and across the global R&D team. The position reports directly to the Manager of Design Engineering. Applicants must be eligible to work in the UK and be on‑site at Falmouth, Cornwall, UK.

Responsibilities

Ensure the safety, effectiveness, and regulatory compliance of medical devices throughout the design and development lifecycle.

Implement and maintain robust quality management systems and lead design quality engineering (DQE) deliverables to support design control activities.

Collaborate with internal and external cross‑functional teams to deliver cutting‑edge medical solutions.

Apply design control principles and quality engineering techniques to influence development efforts and satisfy industry standards, regulatory requirements, and customer needs.

Review scientific and technical data related to product testing, lead problem‑solving efforts, and mentor junior specialists.

Champion continuous improvement initiatives and contribute to product risk management.

Key Responsibilities

Drive and lead validation processes, testing, and verification.

Identify and manage risk.

Engage suppliers and evaluate supplier performance.

Create and support continuous improvement activities.

Oversee CAPA / non‑conformance activities.

Lead design reviews and evaluations.

Communicate key technical content to stakeholders.

Qualifications

BSc / BEng in Electronics, Electrical Engineering, Robotics, Mechatronics, or related fields.

Minimum 4 years of experience in a similar role, preferably in medical device production.

Expertise in analog and digital circuit design and layout using tools such as Altium Schematic Capture.

Strong decision‑making skills across a broad spectrum of quality engineering responsibilities.

Proven experience leading cross‑functional teams in a medical device development environment.

Strong interpersonal, organizational, and project management skills.

Experience with Design for Manufacturing and Assembly (DFMA).

Fluent English (spoken and written) is mandatory.

Seniority Level Mid–Senior level

Employment Type Full‑time

Job Function Quality Assurance – Medical Equipment Manufacturing

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