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The VP of Research and Development (R&D) is responsible for defining and executing the company’s innovation and product development strategy, ensuring a pipeline of differentiated compliant, and commercially successful medical devices. This leader shapes the organization’s technology vision and oversees the full continuum of innovation – from technology exploration, concept generation, product development, and commercialization. They partner cross-functionally to deliver solutions that advance patient outcomes, strengthen the company’s competitive position and drive business growth. The VP of Research and Development provides both strategic direction and hands-on leadership to multi-disciplinary teams and drives the development of technical capabilities, adherence to design controls, and effective design transfers that enable high-quality product launches.
Job Responsibility:
Defines the innovation roadmap, prioritizing opportunities based on unmet clinical needs, market potential, and technical feasibility
Establishes and maintains a strong R&D governance model (Product Development Process stage gates) ensuring disciplined portfolio management and timely decision-making
Oversees all phases of new product development, including concept, feasibility, design and development, verification and validation, design transfer, and post-market stability
Drives excellence in design controls, risk management, human factors, and process validations
Ensure alignment between R&D, Commercial, Operations, Quality, Clinical and Regulatory to facilitate launch readiness
Promotes the development of relationships with external designers and manufacturers that bring capabilities and capacity that support our strategy
Partners with universities, external research groups, suppliers, contract designers and manufacturers, and others to expand the company’s innovation network
Fosters a culture of innovation that balances speed, quality and compliance
Builds and develops a high-performing R&D organization with a clear succession, career development plans, and goals and objectives
Ensures that R&D activities comply with global regulatory and quality system requirements (FDA 21 CFR 820, ISO 13485, MDR, and MDSAP)
Supports preparation of regulatory submissions
Requirements:
Bachelor’s degree in an Engineering or Life Sciences field
Minimum of 15 years of experience in Engineering within the medical device industry
At least 7 years in a leadership or managerial role
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory standards (FDA, ISO 13485, IEC 60601, etc.)
Proven track record of successfully managing cross-functional teams in the development of complex medical devices and bringing Class II or III medical devices from concept to launch
Strong understanding of regulatory, quality, and clinical interface in a global medical device environment
Proven track record of successfully managing relationships with contract designers and manufacturers in the development of complex medical devices
Expertise in systems engineering methodologies, including requirements management, system architecture design, integration, and testing
Experience developing business cases and facilitating project updates to leadership team
Financial and strategic acumen, being able to evaluate trade-offs between innovation, cost, and time to market
Strong problem-solving and analytical skills, with a keen attention to detail
Excellent interpersonal and communication skills, capable of working effectively with both technical and non-technical stakeholders
Ability to manage multiple priorities and projects simultaneously in a fast-paced environment
Experience with project management tools and methodologies
Builds a culture of accountability, innovation and collaboration
Nice to have:
Experience in the development of Class II and Class III medical devices
Knowledge of disposable products and electro-mechanical systems
What we offer:
Incentive compensation program
Comprehensive and competitive range of benefits
Health care benefits
Retirement plans
Work/life benefits
Generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
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