VP Product

Vice President of Product Development - Northwest, USA (CONFIDENTIAL) Northwest, USA Required Experience Minimum 15 years of progressive leadership experience in implantable medical device product development and engineering. Minimum 10 years leading multidisciplinary R&D organizations at the Director, Vice President, or equivalent executive level. Demonstrated success leading the development and commercialization of complex Class II and/or Class III medical devices. Experience managing integrated hardware, software, firmware, systems engineering, and product development teams and directing commercial/manufacturing partners. Proven track record transitioning products from concept and prototype stages through verification, validation, manufacturing transfer, and commercial launch. Experience building and scaling engineering organizations within emerging growth‑stage or venture‑backed medical technology companies strongly preferred. Prior diabetes technology, drug delivery, infusion systems, continuous glucose monitoring (CGM), wearable devices, digital health, or related experience highly desirable. Experience supporting FDA submissions and operating within regulated medical device environments. Required Education Bachelor’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or related technical discipline. Advanced degree (M.S. or Ph.D.) strongly preferred. Job Description Our client is an innovative and rapidly emerging medical technology company dedicated to transforming the lives of people living with diabetes through breakthrough device innovation. The company is developing a first‑in‑class integrated diabetes management platform that combines continuous glucose monitoring and insulin delivery into a single patient‑friendly device. Founded by leading physicians, scientists, and innovators, the organization was established to address one of the most significant unmet needs in diabetes care: improving patient adherence while simplifying disease management. Its proprietary technology has successfully completed key development milestones, including human feasibility studies and biocompatibility validation, and is now advancing toward commercial‑ready product development, pilot manufacturing, regulatory approval, and market introduction. The company is planning its move to a new larger device manufacturing facility in mid‑November. The company’s mission is to improve clinical outcomes, reduce the burden of diabetes management, and increase adoption of advanced diabetes technologies through elegant engineering, patient‑centered design, and scientific excellence. As it enters a pivotal growth phase, the company seeks an accomplished Vice President of Product Development to lead a critical clinical pilot study, manage the transfer to manufacturing and production scaling, direct the commercial design of the product with various manufacturing partners, and plan and deliver the next generation of product development and commercialization efforts. Position Summary Reporting directly to the Chief R&D Officer, the Vice President of Product Development (PD) will provide strategic and operational leadership for all product development, engineering, systems integration, and technology advancement activities across the organization. This executive will lead multidisciplinary teams spanning systems engineering, software, firmware, electrical engineering, mechanical engineering, materials science, product development, and technical program management. The successful candidate will build and scale a world‑class R&D organization capable of transforming advanced concepts into commercially successful medical products by working cross‑functionally inside and outside the organization with multiple key commercial and manufacturing/engineering partners. The VP of PD will play a critical role in defining technology strategy, executing the product roadmap, managing development programs, supporting regulatory submissions, and ensuring successful transition from development through pilot production and commercial manufacturing. This leader must possess the ability to balance strategic vision with hands‑on execution while fostering a culture of innovation, accountability, collaboration, and operational excellence. Key Duties, Activities and Responsibilities Strategic Leadership Develop and execute the company’s overall R&D and product development strategy in alignment with corporate objectives. Partner closely with the CEO and executive leadership team to establish technology priorities, business objectives, and long‑term product roadmaps. Serve as a key member of the executive leadership team, contributing to strategic planning, growth initiatives, fundraising activities, and Board presentations. Identify emerging technologies, competitive trends, and market opportunities that support future product innovation and business growth. Drive innovation with a hands‑on approach while maintaining disciplined development processes and commercialization timelines. Product Development & Engineering Lead all aspects of product development from concept generation through commercialization. Direct multidisciplinary internal and external engineering/manufacturing/commercial teams from key partners responsible for mechanical, electrical, software, firmware, systems engineering, and product integration activities. Ensure all product development activities are executed in accordance with design control requirements and quality system regulations. Establish robust development processes, governance structures, stage‑gate reviews, and project management disciplines. Oversee development of Product Requirements Documents (PRDs), design specifications, verification protocols, validation plans, and technical documentation. Collaborate with Marketing, Clinical Affairs, Regulatory Affairs, Quality, Manufacturing, and Operations to ensure successful product execution. Translate customer, clinical, and market needs into innovative and differentiated product solutions. Drive technical decision‑making and risk management throughout the development lifecycle. Commercialization & Manufacturing Readiness Lead the transition of products from prototype and feasibility stages into pilot production and scalable commercial manufacturing. Collaborate closely with Operations and Manufacturing teams to optimize product design for manufacturability, reliability, quality, and cost with internal groups and outside key partners. Support supplier selection, component qualification, manufacturing transfers, and process validation activities. Ensure readiness for high‑volume production while maintaining product performance and quality standards. Establish systems for effective technology transfer and post‑launch product support. Regulatory, Quality & Compliance Partner with Regulatory Affairs and Quality Assurance teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and applicable global regulatory requirements. Ensure all development activities comply with Quality System Regulations (QSR), Design Controls, Risk Management, and applicable medical device standards. Support regulatory submissions, design reviews, audits, and inspections. Champion quality‑focused product development practices throughout the organization. Organizational Leadership Recruit, develop, mentor, and retain a high‑performing engineering and development organization. Create an environment that promotes innovation, accountability, collaboration, and continuous improvement. Establish organizational structures, succession planning initiatives, performance metrics, and talent development programs. Foster strong cross‑functional partnerships throughout the company and key outside partners/suppliers with a hands‑on leadership style. Build scalable processes and systems capable of supporting future organizational growth. Program & Financial Management Establish and manage departmental budgets, capital expenditures, staffing plans, and external development resources. Oversee project portfolios, resource allocation, milestone tracking, and risk management activities. Ensure programs are delivered on schedule, within budget, and according to product specifications and business objectives. Provide regular updates to executive leadership, investors, and Board members regarding program status and development progress. Knowledge & Skills Education Bachelor’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or related technical discipline required. Advanced degree (M.S. or Ph.D.) strongly preferred. Experience Minimum 15 years of progressive leadership experience in implantable medical device product development and engineering. Minimum 10 years leading multidisciplinary R&D organizations at the Director, Vice President, or equivalent executive level. Demonstrated success leading the development and commercialization of complex Class II and/or Class III medical devices. Experience managing integrated hardware, software, firmware, systems engineering, and product development teams and directing commercial/manufacturing partners. Proven track record transitioning products from concept and prototype stages through verification, validation, manufacturing transfer, and commercial launch. Experience building and scaling engineering organizations within emerging growth‑stage or venture‑backed medical technology companies strongly preferred. Prior diabetes technology, drug delivery, infusion systems, continuous glucose monitoring (CGM), wearable devices, digital health, or related experience highly desirable. Experience supporting FDA submissions and operating within regulated medical device environments. Required Knowledge, Skills & Competencies Strong understanding of systems engineering principles and complex product development methodologies. Deep expertise in medical device development processes, Design Controls, Risk Management, Verification & Validation, and Quality Systems. Knowledge of software development, embedded systems, electronics, sensors, wearable technologies, and connected health platforms. Exceptional leadership, communication, presentation, and team‑building skills. Proven ability to influence stakeholders across technical, clinical, operational, and executive functions. Strong business acumen with the ability to align technology investments with organizational objectives. Demonstrated success managing multiple complex development programs simultaneously. Ability to thrive in a fast‑paced entrepreneurial environment with evolving priorities and limited resources. Excellent analytical, problem‑solving, and decision‑making capabilities. Strong project management and organizational skills with relentless focus on execution and results with both internal cross‑functional groups and external outside partners. Personal Characteristics A visionary technology leader who combines innovation with disciplined execution. A builder of teams, culture, and organizational capability. Highly collaborative and capable of influencing across all levels of the organization. Passionate about improving patient outcomes and advancing diabetes care. Comfortable operating in a dynamic, entrepreneurial environment. Results‑oriented, accountable, and energized by challenging technical problems. Equally effective in strategic planning discussions and hands‑on execution. Compensation & Relocation A highly competitive executive compensation package will be offered, including base salary, annual incentive opportunity, and equity participation. Relocation assistance will be provided for qualified candidates. This position is based onsite in the Northwest, USA and requires regular interaction with engineering, manufacturing, and executive leadership teams. 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