Platform Director

About the Role

The Platform Director leads 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, 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.

Responsibilities

• 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 escalate 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.
• 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.
• Other duties as assigned.

Requirements

Education: Bachelor’s Degree in Engineering

• 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

• 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.