Senior Staff Product Manager

Job Details: Job Location: RALEIGH

• RALEIGH, NC, Position Type: Full Time, Salary Range: Undisclosed, POSITION SUMMARY: Cutera is a global medical device company focused on developing innovative energy-based technologies for dermatology and aesthetic medicine. Our portfolio combines advanced laser, radiofrequency, light-based and other energy technologies with sophisticated handpieces, electronics, software and user interfaces to deliver safe, effective and differentiated clinical solutions. We are seeking a Senior Technical Product Manager to help define, develop and commercialize the next generation of Cutera's energy-based medical devices. This is a highly cross-functional role that sits at the intersection of customers, product strategy, engineering, quality, regulatory, manufacturing and commercial teams. The successful candidate will combine strong product-management discipline with enough technical depth to understand complex medical-device systems and translate customer and clinical needs into actionable product requirements. The Senior Technical Product Manager will own the product strategy, requirements and lifecycle management for assigned Cutera products and technology platforms. The role will serve as a key bridge between the market and technical organization, translating unmet customer needs, clinical requirements, competitive intelligence and business objectives into product strategy, product requirements and development priorities. The ideal candidate has experience developing and commercializing FDA-regulated medical devices, preferably energy-based systems such as lasers, RF, IPL/light, ultrasound or other therapeutic energy technologies. Duties & Responsibilities: Product Strategy & Roadmap 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, product enhancements, platform extensions and technology adjacencies. Develop business cases and recommendations for new product investments. Establish product priorities based on customer value, clinical benefit, technical feasibility, regulatory requirements and business opportunity. Present product strategy and investment recommendations to senior leadership. Customer & Clinical Requirements Develop a deep understanding of physician, clinician and practice workflows. Conduct customer interviews, VOC activities, competitive evaluations and market research. Translate customer and clinical needs into clear, measurable product requirements. Technical Product Definition Develop and maintain Product Requirements Documents (PRDs), User Needs, product specifications and acceptance criteria. Develop sufficient technical understanding of laser, RF, optical, mechanical, electrical, software and control-system technologies to make informed product decisions. Partner with engineering to evaluate technical tradeoffs involving performance, cost, reliability, manufacturability, usability and regulatory requirements. New Product Development Participate in design reviews, risk-management activities, usability activities and development milestones. Support development of prototypes and early product concepts with engineering and clinical teams. Participate in verification and validation planning to ensure product performance addresses defined customer and clinical needs. Regulatory & Quality Work closely with Regulatory Affairs and Quality throughout the product lifecycle. Participate in post-market surveillance, complaint trending and CAPA activities when product-related issues require product-management involvement. Maintain awareness of applicable FDA, ISO 13485, IEC 60601 and other relevant medical-device requirements. Product Lifecycle Management Own the product lifecycle from concept through commercialization, sustaining engineering and end-of-life. Partner with Service and Technical Support to identify recurring field issues and opportunities for product improvement. Develop product lifecycle plans, including upgrades, accessories, handpieces, consumables and technology extensions. Commercialization & Launch Partner with Marketing and Commercial teams to develop product positioning, messaging and launch strategies. Develop product launch plans, training requirements and commercial readiness criteria. Participate in major customer meetings, trade shows, KOL events and product demonstrations. Competitive Intelligence & Innovation Monitor competitor products, clinical claims, treatment protocols, pricing, business models and technology developments. Evaluate emerging technologies including new laser wavelengths, RF architectures, energy-delivery systems, sensors, imaging, software and AI-enabled capabilities. Cross-Functional Leadership Act as the product leader across Engineering, R&D, Clinical, Regulatory, Quality, Operations, Manufacturing, Service, Sales, and Marketing. Effectively communicate complex technical and clinical concepts to both technical and non-technical audiences. Other duties as needed or required.

Qualifications

MINIMUM REQUIREMENTS & QUALIFICATIONS: 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. Demonstrated ability to translate customer and clinical requirements into technical product requirements. Strong understanding of product lifecycle management. Demonstrated ability to influence cross-functional teams without direct authority.

PREFERRED QUALIFICATIONS

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 is a plus. ADDITIONAL REQUIREMENTS: 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.