Senior Staff Product Manager

Cutera, Inc.•Raleigh, NC

About The Position

Cutera is a global medical device company focused on developing innovative energy-based technologies for dermatology and aesthetic medicine. Its portfolio combines laser, radiofrequency, light-based and other energy technologies with handpieces, electronics, software and user interfaces to deliver clinical solutions. The Senior Technical Product Manager owns product strategy, requirements and lifecycle management for assigned Cutera products and technology platforms. The role bridges customers and the technical organization, translating customer and clinical needs, competitive intelligence and business objectives into product strategy, requirements and development priorities. It partners across engineering, quality, regulatory, manufacturing, clinical, service, sales and marketing to define and commercialize next-generation energy-based medical devices.

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, including 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 to evaluate technical tradeoffs involving performance, cost, reliability, manufacturability, usability and regulatory requirements.
Participate in design reviews, risk-management activities, usability activities and development milestones; support prototypes and early product concepts.
Participate in verification and validation planning to ensure product performance addresses customer and clinical needs.
Work with Regulatory Affairs and Quality throughout the product lifecycle, including involvement in post-market surveillance, complaint trending and CAPA activities when required.
Own product lifecycle management from concept through commercialization, sustaining engineering and end-of-life; develop lifecycle plans for upgrades, accessories, handpieces, consumables and technology extensions.
Partner with Service and Technical Support to identify recurring field issues and product-improvement opportunities.
Partner with Marketing and Commercial teams on product positioning, messaging and launch strategies; develop launch plans, training requirements and commercial readiness criteria.
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 collaboration 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.