Senior Manager I, Patient‑Specific Instrumentation Products

Senior Manager I, Patient‑Specific Instrumentation Products

  POSITION PROFILE

 

Lead the strategy, portfolio, and performance of our patient specific instrumentation category, encompassing 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. Includes: Portfolio strategy & roadmap across software, models, guides, and implants, including 3rd‑party products included in the portfolio, to meet revenue, margin, and clinical impact targets. End‑to‑end lifecycle: innovation, R&D prioritization, design controls, launch excellence, post‑market performance, continuous improvement, and EOL. Alliance/partner ecosystem providing critical inputs and clinical value such as segmentation software, engineering applications, digital surgical planning, adjacent surgical tools, and patient-matched implant manufacturers. Category performance: growth, gross margin, quality, reliability, and customer satisfaction metrics. Team leadership across Product, Portfolio, R&D, and Alliance Management. Location: Remote, Hybrid, or Raleigh-Durham-Chapel Hill, NC.

 

Job Duties and Responsibilities

Strategy & Portfolio

• Build and maintain a 3‑year portfolio strategy and evidence plan; run stage‑gate governance tailored to patient‑specific devices.
• Focus portfolio strategy to unmet clinical needs, work with KOLs and Customers to validate concepts, and target value from point-of-care service delivery model.
• Partner with Regulatory and Quality to understand and apply regulatory strategies to product development (e.g., 510(k)/De Novo/PMA, as applicable), 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).

Innovation and R&D

• Translate VOC and KOL input into high‑value use cases (e.g., osteotomies, complex recon) and prioritized roadmaps.
• Lead team of R&D professionals, engineers, and clinical resources through technical design and development of patient-specific devices. Responsible for physical R&D facility, associated clinical and academic relationship, and FTE’s located at the site. 
• Oversee requirements, design verification/validation, usability/human factors, and design transfer for both centralized and POC 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.

Commercialization and Product Management

Alliance Management

• Stay abreast of state-of-the art technology for key inputs to products and valuable adjacent products through robust market research and benchmarking. Source, evaluate, and onboard partners.
• Create repeatable partnership appropriateness 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).

Financials & Performance

• 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 multi-year R&D budget to ensure development of needed devices within economic means of company. 

People & Culture

• 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.

 

QUALIFICATIONS (Education, Experience, and Certifications)

• 10+ years in medical devices, with 5+ years leading product/portfolio teams; 3+ years managing people.
• Demonstrated expertise of 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 related; advanced degree (MS, PhD, MBA) preferred.

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.

 

KNOWLEDGE, Skills And Abilities

• Excellent verbal and written communication skills, as well as the ability to understand technical documentation.
• Must work equally well independently. The successful candidate will be project oriented with the ability to stay on task, but with considerable variety between tasks.
• Willingness to adapt to a changing work environment and duties.
• Highly motivated with the ability to handle multiple assignments and operate effectively in a fast paced environment.
• Ability to write technical analysis documentation, create business presentations and deliver business updates on technical subjects to an audience with a range of technical knowledge.
• Ability to work with and train others on the research and innovation program.
• Ability to speak effectively before groups of customers or peers.
• Ability to develop a high performance culture with clear expectations of performance. 
• Ability to evaluate work-flows and develop improvement strategies.
• Ability to effectively envision, develop and implement new strategies to address complex business issues.
• Possess strong leadership, strategic, analytical, and organizational skills.
• Adapts to changing circumstances and works confidently despite stressful situations.
• Possesses ability to effectively utilize standard business software applications.
• Displays good judgment - makes sound, justifiable decisions and takes action in solving problems. 
• Ability to collect, organize and analyze data utilizing statistical methods.
• Maintains positive employee relations - possesses ability to establish effective communication with direct reports by encouraging open and honest communication; receiving and giving feedback.
• Remains updated on current technology and trends in the industry.
• Possess strong personnel development skills. 

 

Working Conditions, MENTAL aND PHYSICAL DEMANDS

• Work is performed in multiple types of environments including typical office and light manufacturing.
• Requires regular communication with customers and business associates.
• Work has stress due to the impact the incumbent's decisions have on the business results.
• Minor physical effort is required, which may involve long periods of standing, walking or similar activities 
• Requires moderate dexterity - regular application of basic skills (calculator, keyboard, etc.) 
• Travel up to 60%

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.

Come Create at Ricoh:

If you are seeking a team driven by passion and purpose, come create with us at Ricoh. We are a team of information seekers and customer-obsessed collaborators who aspire to deliver the services, solutions, and technologies that empower business success. We are looking for talented, inspired individuals to join us to help drive high-performance team and our commitment to excellence.

Ricoh is an integrated solutions provider and partner that connects people and technology, creates outstanding customer experiences, and delivers innovation for businesses worldwide. We empower digital workplaces by enabling individuals to work smarter from any location and harness the power of information—how it is collected, stored, managed, and shared—to unlock the potential in every organization. We deliver services and technologies that inspire our customers’ success and guide them toward a better and more sustainable future. If you are seeking a purpose-driven and passionate team, come create with us, and help drive our high-performance culture of excellence into tomorrow.

Invest in Yourself:

At Ricoh, you can:

• 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.