1) Strategy & Leadership

• Serve on the ELT; translate the company strategy into a prioritized, resourced, and time-phased R&D roadmap tied to launch readiness for PHR and THA.

• Establish a tiered operating cadence (daily/weekly/monthly) linking R&D outputs to validation, supplier qualification, and regulatory submissions.

• Represent JointMedica’s technical vision and progress to the President, ELT, surgeons, external partners, and the Board.

2) Design Control, DHF Remediation & QMS/Regulatory Integration

• Own Design History File (DHF) remediation: lock scope, drive document velocity, and keep change control clean across design inputs/outputs, risk management, verification/validation, and traceability.

• Ensure design control rigor and alignment with ISO 13485 and applicable ASTM/ISO standards; partner with Regulatory to support FDA, CE, and UKCA submissions with complete, inspection-ready evidence sets.

• Proactively harmonize R&D processes with QMS expectations; monitor CAPA, ECN/CO cycle times, and document throughput to sustain audit readiness.

3) Bench Testing, Evidence Generation & Manufacturing Feedback Loop

• Lead the evidence strategy for wear, biocompatibility, material characterization, coating adhesion, mechanical, and fatigue testing across multiple vendors.

• Ensure test coupons replicate production processes; keep supplier qualifications, validations, and travelers synchronized with evolving test evidence and manufacturing methods.

• Translate test findings into controlled process changes and validation plans; maintain strict configuration management so design → test → manufacturing stays coherent.

4) Materials & Manufacturing Translation

• Drive JointMedica’s materials evolution across highly cross-linked and Vitamin E polyethylene, ceramics, cobalt-chromium femoral heads, and related coatings/surfaces.

• Partner with Manufacturing/Operations and Supply Chain to enable robust process windows, validation strategies, and cost-effective scaling; ensure DFM/DFA and supplier readiness from prototype through serial production.

5) Computer-Assisted Surgery (CAS), Computer Navigation & PSI Strategy

• Provide strategic guidance and technical leadership for JointMedica’s CAS/computer navigation roadmap and Patient-Specific Instrumentation (PSI) initiatives.

• Define platform architecture, data and imaging workflows, accuracy/tolerance requirements, and verification/validation strategies; align surgeon unmet needs with regulatory pathways and manufacturability.

• Build external collaborations, as necessary (universities, software partners, imaging vendors) to accelerate development and clinical credibility.

6) Surgical Instruments & Approach-Specific Tooling (Direct Anterior THA & Hip Resurfacing)

• Collaborate closely with leading hip surgeons to define clinical requirements, sequence of steps, and constraints for alternate surgical approaches, including direct anterior total hip arthroplasty and direct anterior hip resurfacing.

• Lead design and development of approach-specific instruments: acetabular preparation systems (reamers/reamer drivers, alignment/orientation guides), femoral preparation tools (broaches, rasps, calcar/neck osteotomy guides), resurfacing-specific jigs and drill guides, low-profile retractors, and soft-tissue–sparing accessories.

• Design for operating-room workflow compatibility (e.g., DA tables, fluoroscopic guidance, minimal-incision access), ensuring ergonomic handling, intuitive use, and reduced instrument counts through efficient kitting/sterilization tray layouts.

• Integrate PSI and CAS: incorporate approach-specific PSI guides and CAS compatibility (e.g., registration landmarks, tracking interfaces) to improve accuracy and repeatability.

• Drive verification, validation, and simulated-use testing (cadaver labs, usability/human-factors evaluation); own IFU development, cleaning/sterilization validations, and packaging/UDI requirements for instrument sets.

• Stand up a structured KOL collaboration program (design sprints, cadaveric evaluations, formative/summative usability) with fast feedback loops into design iterations and risk management files.

• Ensure DFM/DFA and cost-effective manufacturability; qualify instrument suppliers, manage PPAP/FAI, and set maintenance/refurbishment standards for fielded kits.

• Coordinate IP strategy (freedom to operate, invention disclosures, and filings) for novel approach-specific instruments and methods.

7) External Vendors, Labs & In-House Test Capability

• Select and manage high-quality outsourced testing labs and specialized research partners; negotiate scopes, SLAs, and data integrity standards.

• Oversee the staged build-out of in-house bench testing capabilities (e.g., wear, mechanical/fatigue, metrology), including equipment selection, method validation, and staffing/training plans.

• Identify and qualify contract manufacturers with the right process maturity, quality culture, and capacity; own the technical aspects of tech transfer, PPAP/FAI, and ongoing process capability monitoring.

8) Cross-Functional R&D Integration

• Work with Quality, Regulatory, and Manufacturing to set a technical strategy that translates new technologies into approvals and reliable production.

• Build a single, synchronized plan spanning DHF, test workstreams, validations, supplier qualification, and submission milestones.

9) Board & Stakeholder Engagement

• Prepare high-quality, insight-driven Board materials (technical progress, risk/mitigation, evidence status, cost/COGS impacts, and schedule adherence).

• Present complex technical topics in crisp, decision-oriented formats for the President, ELT, and Board; maintain a transparent risk register with clear mitigations and owners.

10) People Leadership & Culture

• Build and mentor a multidisciplinary R&D team; model a culture that follows JointMedica’s company cultural values: 1) patient-focused, 2) nurturing, 3) agile, 4) efficient, 5) creative, and 6) collaborative.

• Calibrate roles, fill critical gaps, and coach team members to sustain a high-velocity, compliant, and collaborative execution rhythm.