Job DescriptionResponsible 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.
ResponsibilitiesEssential Functions & Accountabilities:- 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.
Travel:- Up to 20% travel, including domestic and occasional international travel to manufacturing sites, suppliers, and global team meetings.
QualificationsKnowledge, Skills and Abilities:- 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.
Work Environment:- Primarily office and laboratory-based environment with occasional manufacturing floor exposure.
- Prolonged periods of sitting and computer use.
- Interaction with lab equipment and product testing environments.
- Minimal physical exertion required; occasional lifting of materials or equipment.
Experience:- 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.
Education:- Minimum Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related discipline).
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.
