Manager, Product Engineering (Research & Development)

CooperCompanies•Trumbull, CT

4d•Hybrid

About The Position

Responsible for leading product engineering activities across the Medical Device portfolio within CooperSurgical, supporting both sustaining engineering and new product introduction. This role influences global product performance, lifecycle management, and regulatory compliance for a multi-product portfolio. Interfaces cross-functionally with R&D, Quality, Regulatory Affairs, Operations, Marketing, and external suppliers to deliver product enhancements, address field issues, and ensure ongoing product reliability and compliance. Works across regions and global manufacturing sites, with responsibility for technical decision-making and execution aligned with business objectives. The Manager, R&D Product Engineering leads a team responsible for sustaining engineering and lifecycle management. This role ensures product quality, compliance, and performance through design improvements, risk management, and resolution of complex technical issues. The position partners cross-functionally to support product launches, manufacturing transfers, and continuous improvement initiatives, while driving technical excellence and ensuring alignment to CooperSurgical’s strategic goals.

Requirements

Strong knowledge of medical device product development and sustaining engineering processes.
Deep understanding of regulatory requirements (FDA, ISO 13485, MDR) and design control processes.
Demonstrated ability to lead root cause analysis and problem-solving using structured methodologies (e.g., Six Sigma, 8D, DMAIC).
Proven leadership and team management skills, with the ability to develop and motivate engineering teams.
Strong cross-functional collaboration and stakeholder management skills.
Excellent written and verbal communication skills, including the ability to communicate complex technical concepts clearly.
Ability to manage multiple projects and priorities in a fast-paced environment.
Significant experience in medical device product engineering, R&D, or sustaining engineering roles.
Demonstrated experience bringing medical devices to market.
Prior experience leading engineering projects or technical teams.
Minimum Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related discipline).

Responsibilities

Lead and manage product engineering activities for the Medical Device portfolio, ensuring product performance, quality, and compliance throughout the lifecycle.
Manage, coach, and develop a team of product engineers, including hiring, goal setting, performance management, and career development.
Drive design changes, product improvements, and cost reduction initiatives based on field feedback, complaint investigations, and business priorities.
Partner with Quality and Regulatory Affairs to ensure compliance with applicable standards (e.g., FDA, ISO 13485, MDR) and to support audits, CAPAs, and submissions.
Oversee root cause investigations and corrective/preventive actions for product issues, ensuring timely resolution and effective risk mitigation.
Support new product introductions (NPI), design transfers, and manufacturing scale-up activities in collaboration with R&D and Operations.
Ensure design history files (DHF), technical documentation, and engineering records are maintained in compliance with company and regulatory requirements.
Collaborate with suppliers and external partners to resolve technical issues, improve product quality, and ensure supply continuity.
Provide technical leadership and decision-making for complex engineering challenges, balancing risk, cost, and timeline considerations.
Drive continuous improvement in engineering processes, tools, and methodologies to enhance efficiency and product quality.
Communicate project status, risks, and key metrics to the Global Director of Product Engineering and cross-functional stakeholders.
Participate in strategic planning and portfolio management activities, contributing to roadmap development and prioritization.