Platform Director

The Platform Director is responsible for leading a product platform within ORS’ R&D organization, with accountability for platform strategy, technical execution, cross-functional alignment, and delivery of product development and sustaining engineering initiatives. This role serves as the primary R&D leader for the assigned platform and is responsible for coordinating internal and external resources to ensure high-quality, timely, and compliant execution of development programs, design changes, and product improvement efforts. The Platform Director operates within a platform/functional hybrid model and partners closely with shared engineering disciplines, Program Management, Quality, Regulatory, Operations, Product Management, and external development partners. This role is expected to provide strong leadership, clear decision-making, and disciplined execution across the full product lifecycle. PRIMARY (Essential) FUNCTIONS: Lead the R&D strategy, priorities, and execution for an assigned platform, including new product development, sustaining engineering, and product lifecycle improvements. Serve as the primary technical and organizational leader for the platform, ensuring alignment of workstreams across engineering, quality, regulatory, operations, and commercial needs. Partner with Program Management to establish and maintain platform plans, schedules, milestones, resource needs, and execution priorities. Drive technical decision-making for the platform, including tradeoff assessments related to performance, risk, cost, timeline, manufacturability, serviceability, and compliance. Provide leadership and oversight for product changes, design updates, remediation efforts, product line extensions, and other development activities affecting the platform. Ensure platform development activities are executed in accordance with applicable quality system requirements, design control processes, and internal procedures. Lead and coordinate internal engineering disciplines and external development partners to meet program objectives and deliverables. Establish strong working relationships with shared functional engineering leaders to ensure appropriate technical support, resource planning, and execution quality. Collaborate with Quality and Regulatory teams to support design reviews, risk management, verification/validation activities, submissions, remediation efforts, and compliance objectives. Partner with Operations, Supply Chain, and Manufacturing to support transfer to production, design for manufacturability, product reliability, and continuous improvement. Maintain visibility to platform risks, issues, and dependencies; proactively elevate and drive resolution as needed. Contribute to annual planning, budgeting, and forecasting for platform-related activities and resource needs. Support organizational development, including hiring, talent development, mentoring, and performance management of assigned staff. Build and maintain a culture of accountability, technical rigor, collaboration, and execution excellence. Other duties as assigned.

OTHER FUNCTIONS:

Support due diligence, technical assessment, and integration activities for external development or partnership opportunities as needed. Provide subject matter input to strategic planning and long‑range product/platform roadmap discussions. Represent the platform in executive reviews, cross‑functional governance forums, and external partner discussions. Requirements: Education/Training/ Certifications/Licenses: Bachelor’s Degree in Engineering Experience: Minimum 10 years of experience in medical device engineering and/or product development in an FDA‑regulated environment. Minimum 5 years of leadership experience managing technical teams, complex product development efforts, or major platform/program responsibilities. Demonstrated experience leading cross‑functional product development and sustaining engineering initiatives. Experience working with external design/development partners, contract engineering firms, or manufacturing partners strongly preferred. Experience with design controls, risk management, verification/validation, and regulated product lifecycle processes required. Experience supporting products with electro‑mechanical, software, or systems integration complexity preferred. Skills/`Abilities: Strong technical leadership with the ability to balance strategic direction and hands‑on execution oversight. Strong cross‑functional collaboration and influence skills. Ability to drive decisions, alignment, and accountability across matrixed teams. Strong understanding of medical device development processes, change control, and quality system expectations. Ability to identify and resolve complex technical and organizational issues in a timely manner. Effective written and verbal communication skills, including the ability to communicate clearly with technical and non‑technical stakeholders. Strong project and execution management capability. Working knowledge of tools used in engineering, product development, and document control environments. #J-18808-Ljbffr Organ Recovery Systems