Sr. Manager - Patient Specific Instrumentation

FloodGate Medical•Tampa, FL

23d•Onsite

About The Position

Ricoh 3D for Healthcare delivers patient-specific, 3D-printed anatomical models that help clinicians enhance surgical planning, improve precision, and support better patient outcomes. By combining advanced 3D printing technology with medical imaging, Ricoh provides customized solutions that bring greater clarity to complex cases. Their innovative approach streamlines workflows for healthcare providers while supporting more personalized, efficient, and effective care. Why You Should Join Us In the Sr. Manager - Patient Specific Instrumentation role, you will 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. Ideally, this role will be located on-site in the Raleigh/Durham, NC area. However, this is flexible for the right candidate.

Requirements

Demonstrated expertise in 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 datadriven decision making.
Bachelor’s in engineering, biomedical, or related; advanced degree (MS, PhD, MBA) preferred.

Nice To Haves

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.

Responsibilities

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.