Ricoh Americas Holdings is hiring a Senior Manager to lead the strategy, portfolio, and performance of our patient-specific instrumentation category. This encompasses anatomic models, software, surgical guides, and patient-matched implants. You will own innovation through end of life, orchestrate enabling alliances, and scale compliant, profitable productized services that improve surgical planning and execution.
What You'll Do
- Build and maintain a 3-year portfolio strategy and evidence plan; run stage-gate governance tailored to patient-specific devices.
- Focus portfolio strategy on unmet clinical needs, work with KOLs and customers to validate concepts, and target value from a point-of-care service delivery model.
- Partner with Regulatory and Quality to understand and apply regulatory strategies (e.g., 510(k)/De Novo/PMA), maintain design history and risk files, and ensure final ISO 13485/21 CFR 820 compliance.
- Own make/partner/buy decisions with robust business cases (NPV, risk, cost-to-serve, regulatory pathways).
- Translate VOC and KOL input into high-value use cases (e.g., osteotomies, complex recon) and prioritized roadmaps.
- Lead a team of R&D professionals, engineers, and clinical resources through technical design and development of patient-specific devices.
- Be responsible for a physical R&D facility, associated clinical and academic relationships, and FTEs located at the site.
- Oversee requirements, design verification/validation, usability/human factors, and design transfer for both centralized and point-of-care delivery.
- Ensure launch readiness by providing expertise to appropriate teams (reimbursement, claims, labeling/IFU, marketing, manufacturing, training, service delivery model, post-launch monitoring).
- Define pricing and commercialization playbooks with Marketing and Sales; align with reimbursement strategy and enterprise health system contracting.
- Align with Service Excellence, Sales, Marketing, and service delivery teams to track product performance and customer feedback for continuous improvement.
- Coordinate clinical evidence generation and publications supporting claims and customer value.
- Plan product sunset strategy, manage transition to next-gen solutions, and ensure alignment with regulatory compliance during phase-out.
- Stay abreast of state-of-the-art technology through robust market research and benchmarking. Source, evaluate, and onboard partners.
- Create a repeatable partnership evaluation framework, qualification process, and audit strategy.
- Negotiate agreements (with Legal/RA/QA): Memorandums of Understanding, Teaming Agreements, IP ownership/improvements, data rights, exclusivity/territory, quality agreements, service levels, and commercial terms.
- Manage partner performance (QBRs, scorecards) and lifecycle (renewals, extensions, terminations, transitions).
- Work cross-functionally to ensure portfolio product mix meets category revenue and margin targets.
- Build dashboards for product performance, adoption, quality, and clinical value; drive appropriate cross-functional communication cadences.
- Manage a multi-year R&D budget to ensure development of needed devices within economic means of the company.
- Hire, develop, and lead a high-performing team; set clear objectives, coach for outcomes, and foster accountability and collaboration.
- Champion a culture of quality, innovation, continuous improvement, and customer-centricity.
What We're Looking For
- 10+ years in medical devices, with 5+ years leading product/portfolio teams; 3+ years managing people.
- Demonstrated expertise with patient-specific or procedure-enabling products (e.g., surgical guides, custom implants, planning software) and cross-functional commercialization activities.
- Working knowledge of design controls, risk management, and QMS (ISO 13485, 21 CFR 820) and familiarity with ISO 14971, IEC 62366 (human factors); exposure to ISO 10993 and sterilization pathways.
- Experience with DICOM-to-CAD workflows, surgical digital planning, and additive manufacturing supply chains.
- Experience with alliance/partner management and contract negotiation as the business representative (with Legal/RA/QA support).
- Strong financial acumen (business cases, pricing, portfolio ROI) and data-driven decision making.
- Bachelor’s in engineering, biomedical, or a related field.
Nice to Have
- Advanced degree (MS, PhD, MBA) preferred.
- Understanding of point-of-care manufacturing or embedded hospital services.
- Regulatory exposure to 510(k)/De Novo/PMA strategies.
- Experience with hospital IT/security and navigating HIPAA/BAAs and vendor risk assessments.
- Background collaborating with KOLs and running/overseeing clinical studies.
Team & Environment
You will provide team leadership across Product, Portfolio, R&D, and Alliance Management functions. We are a team driven by passion and purpose, comprised of information seekers and customer-obsessed collaborators who aspire to deliver services, solutions, and technologies that empower business success within a high-performance culture of excellence.
Benefits & Compensation
- Choose from a broad selection of medical, dental, life, and disability insurance options.
- Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments.
- Augment your education with team member tuition assistance programs.
- Enjoy paid vacation time and paid holidays annually.
- Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development.
Work Mode
This role offers a hybrid work mode. Candidates can be considered for Remote, Hybrid, or Raleigh-Durham-Chapel Hill, NC locations.
