Vice President, Research and Development

Vice President, Research and Development CooperSurgical - 3.4 Trumbull, CT Job Details Full-time 23 hours ago Benefits Health insurance Paid time off Parental leave Qualifications New product development Team management Research and development project management Research & development Healthcare compliance Full Job Description The Vice President of Research & Development (VP, R D) is a senior executive responsible for defining and executing the company's innovation strategy to deliver safe, effective, and commercially successful medical devices. This leader will oversee the full product lifecycle—from concept and feasibility through development, verification/validation, regulatory submission, and post‑market support—while ensuring alignment with business objectives, regulatory requirements, and patient needs. The Vice President leads a Research and Development organization of 75 team members and partners closely with Regulatory, Quality, Clinical, Operations, and Commercial leaders to accelerate time‑to‑market, build scalable development capabilities, and foster a culture of scientific excellence, accountability, and innovation. 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.

Knowledge, Skills and Abilities:

Required:

PhD, MS, or equivalent advanced degree in Engineering, Computer Science, Biomedical Engineering, or related field. 15+ years of progressive R D leadership experience in medical devices, digital health, or regulated healthcare technology. Proven track record delivering software‑ and AI‑enabled medical products from concept to global commercialization. Deep knowledge of medical device regulations, software standards, and AI governance in regulated environments. Extensive experience operating within public company governance and compliance frameworks.

Preferred:

Prior P&L or portfolio leadership responsibility. Experience with cloud‑based platforms, data pipelines, cybersecurity, and AI lifecycle management. Exposure to M&A technical due diligence and post‑acquisition integration. Global leadership experience across North America, Europe, and Asia.

Leadership Competencies:

Strategic & Systems Thinker:

Integrates hardware, software, data, and AI into cohesive platforms. Execution‑

Driven:

Delivers predictable outcomes in fast‑moving, highly regulated environments.

Technically Credible:

Respected by engineers, clinicians, regulators, and executive peers. Board‑

Ready Communicator:

Engages effectively with executive leadership and Directors. Patient‑

First Mindset:

Anchors innovation in safety, usability, and clinical outcomes. 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. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at .

Essential Functions & Accountabilities:

R D & Technology Strategy:

Define and execute a long‑term R D strategy that integrates medical hardware, embedded software, cloud platforms, data analytics, and AI/ML capabilities. Build and manage a balanced portfolio spanning incremental innovation, platform development, and disruptive technologies. Align R D priorities with corporate strategy, multi‑year financial plans, and public company growth commitments. Software & AI‑

Enabled Product Development:

Lead development of software‑as‑a‑medical‑device (SaMD), software in a medical device (SiMD), digital health platforms, and AI/ML algorithms. Establish development practices compliant with

IEC 62304, FDA

SaMD guidance, Good Machine Learning Practices (GMLP), and cybersecurity standards. Ensure AI systems are clinically validated, explainable, secure, and ethically deployed, with strong post‑market monitoring and model lifecycle management.

Regulatory, Quality & Compliance Leadership:

Ensure R D outputs meet global regulatory requirements including FDA, EU MDR/IVDR, and international software and AI regulations. Partner with Regulatory and Quality to support major submissions, inspections, and responses to regulatory inquiries. Embed quality‑by‑design, software risk management, data integrity, and cybersecurity throughout development.

Clinical & Evidence Strategy:

Collaborate with Clinical Affairs to generate clinical evidence supporting software, algorithms, and connected device claims. Support real‑world evidence (RWE) and data‑driven performance monitoring post‑launch. Integrate human factors, usability engineering, and patient experience into product design.

Public Company Governance & Executive Accountability:

Provide clear, data‑driven updates on R D performance, risks, and milestones to executive leadership and the Board of Directors. Support investor confidence through predictable execution, portfolio clarity, and credible long‑range innovation plans. Partner with Finance and Legal to support earnings forecasts, disclosures, and risk management related to R D initiatives.

Leadership & Organization Development:

Build and lead world‑class, multidisciplinary teams spanning hardware, software, data science, systems engineering, and clinical. Attract, retain, and develop top technical and leadership talent in competitive global markets. Foster a culture of accountability, innovation, and continuous improvement.

Operational Excellence & Scalability:

Implement modern development tooling, agile practices (where appropriate), and portfolio governance to improve speed and predictability. Optimize R D spending, vendor strategy, and global development footprint. Ensure design for manufacturability, scalability, and lifecycle cost efficiency.

Travel:

Able to travel 25% + (60+ days) nationally and internationally.