R&D Product Manager

CUTERA INC•Raleigh, NC

About The Position

Cutera is a global medical device company focused on developing energy-based technologies for dermatology and aesthetic medicine. The R&D Product Manager will define, develop, and commercialize the next generation of Cutera energy-based medical devices. This cross-functional role connects customers and product strategy with engineering, quality, regulatory, manufacturing, and commercial teams. The role owns product strategy, requirements, and lifecycle management for assigned products and technology platforms. It translates customer and clinical needs, competitive intelligence, and business objectives into product strategies, requirements, and development priorities. The position requires product-management discipline and technical understanding of complex medical-device systems, ideally including energy-based technologies.

Requirements

Bachelor's degree in Engineering, Biomedical Engineering, or a related discipline.
8–13+ years of experience in product management, product development, engineering, or a closely related role.
Experience developing and commercializing FDA-regulated medical devices.
Demonstrated experience taking products from concept through development, regulatory clearance, and commercial launch.
Strong understanding of medical-device product development processes.
Ability to translate customer and clinical requirements into technical product requirements.
Strong understanding of product lifecycle management.
Ability to influence cross-functional teams without direct authority.
Ability to work in both office and remote environments.
Ability to travel domestically and internationally up to approximately 25%.
Ability to sit, stand, and use standard office equipment for extended periods.

Nice To Haves

Experience with laser, RF, IPL, light, ultrasound, microwave, or other energy-based medical devices.
Experience with dermatology, aesthetics, ophthalmology, or other procedural medical devices.
Experience with IEC 60601, IEC 60825, ISO 14971, and IEC 62366.
Experience supporting FDA 510(k) and international regulatory submissions.
Experience with medical-device service, field reliability, and sustaining engineering.
MBA or advanced technical degree.

Responsibilities

Develop and maintain product strategies and multi-year roadmaps; define product vision, positioning, target customers, clinical applications, and business objectives.
Identify opportunities for new products, enhancements, platform extensions, and technology adjacencies; develop business cases and investment recommendations.
Prioritize products based on customer value, clinical benefit, technical feasibility, regulatory requirements, and business opportunity, and present recommendations to senior leadership.
Understand physician, clinician, and practice workflows through customer interviews, voice-of-customer activities, competitive evaluations, and market research.
Translate customer and clinical needs into clear, measurable product requirements.
Develop and maintain Product Requirements Documents, User Needs, product specifications, and acceptance criteria.
Partner with engineering on technical tradeoffs involving performance, cost, reliability, manufacturability, usability, and regulatory requirements.
Participate in design reviews, risk-management and usability activities, development milestones, prototype and concept development, and verification and validation planning.
Work with Regulatory Affairs and Quality throughout the product lifecycle; participate in post-market surveillance, complaint trending, and CAPA activities when product-management involvement is needed.
Own product lifecycle management from concept through commercialization, sustaining engineering, and end-of-life.
Partner with Service and Technical Support to identify recurring field issues and product-improvement opportunities; develop lifecycle plans for upgrades, accessories, handpieces, consumables, and technology extensions.
Partner with Marketing and Commercial teams on product positioning, messaging, launch strategies, launch plans, training requirements, and commercial readiness.
Participate in major customer meetings, trade shows, KOL events, and product demonstrations.
Monitor competitor products, clinical claims, treatment protocols, pricing, business models, and technology developments; evaluate emerging technologies.
Lead cross-functional product work across Engineering, R&D, Clinical, Regulatory, Quality, Operations, Manufacturing, Service, Sales, and Marketing.
Communicate complex technical and clinical concepts to technical and non-technical audiences.
Perform other duties as needed or required.