Vice President, Research and Development
Trumbull, CT - USA
Job Summary
The Vice President of Research & Development (VP R&D) is a senior executive responsible for defining and executing the companys innovation strategy to deliver safe effective and commercially successful medical devices. This leader will oversee the full product lifecyclefrom concept and feasibility through development verification/validation regulatory submission and postmarket supportwhile 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 timetomarket build scalable development capabilities and foster a culture of scientific excellence accountability and innovation.
Responsibilities
Essential Functions & Accountabilities:
R&D & Technology Strategy:
- Define and execute a longterm 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 multiyear financial plans and public company growth commitments.
Software & AIEnabled Product Development:
- Lead development of softwareasamedicaldevice (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 postmarket 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 qualitybydesign 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 realworld evidence (RWE) and datadriven performance monitoring postlaunch.
- Integrate human factors usability engineering and patient experience into product design.
Public Company Governance & Executive Accountability:
- Provide clear datadriven 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 longrange 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 worldclass 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 travel25% (60 days) nationally and internationally.
Qualifications
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 AIenabled 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 cloudbased platforms data pipelines cybersecurity and AI lifecycle management.
- Exposure to M&A technical due diligence and postacquisition integration.
- Global leadership experience across North America Europe and Asia.
Leadership Competencies:
- Strategic & Systems Thinker: Integrates hardware software data and AI into cohesive platforms.
- ExecutionDriven: Delivers predictable outcomes in fastmoving highly regulated environments.
- Technically Credible: Respected by engineers clinicians regulators and executive peers.
- BoardReady Communicator: Engages effectively with executive leadership and Directors.
- PatientFirst Mindset: Anchors innovation in safety usability and clinical outcomes.
As an employee of CooperSurgical youll 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 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 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
Required Experience:
Exec
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.