Ricoh UK

Senior Manager I, Patient-Specific Instrumentation Products

Ricoh UK

full-time

Posted on:

Location Type: Hybrid

Location: Raleigh • North Carolina • United States

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Job Level

Senior

About the role

  • Lead the strategy, portfolio, and performance of our patient specific instrumentation category.
  • Own innovation through end of life, orchestrate enabling alliances, and scale compliant, profitable productized services.
  • Build and maintain a 3‑year portfolio strategy and evidence plan.
  • Partner with Regulatory and Quality to understand and apply regulatory strategies to product development.
  • Own make/partner/buy decisions with robust business cases.
  • Lead team of R&D professionals, engineers, and clinical resources through technical design and development of patient-specific devices.
  • Ensure launch readiness by providing expertise to appropriate teams.
  • Define pricing and commercialization playbooks with Marketing and Sales.

Requirements

  • 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.
  • 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.
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
patient-specific instrumentationsurgical guidescustom implantsplanning softwaredesign controlsrisk managementQMSDICOM-to-CAD workflowsadditive manufacturingfinancial acumen
Soft Skills
leadershipstrategic planningdata-driven decision makingcollaborationnegotiation
Certifications
Bachelor’s in engineeringBachelor’s in biomedicaladvanced degree (MS, PhD, MBA)