Research and Development Project Manager

Job Title: R&D Project Manager

Location: Bellevue, Washington (Hybrid Role)

Reports To: VP of Product Development and COO

Position Summary:

We are seeking an experienced and highly motivated R&D Project Manager to lead and coordinate multiple medical device development projects simultaneously: typically, 2-3 major, 2-3 sustaining. The development projects span software, hardware/firmware, and manufacturing within our R&D organization. This role is responsible for managing both internal cross-functional teams and external consulting/service companies to deliver products on time, within budget, and with documentation suitable for FDA 510(k) submission.

The ideal candidate brings a strong blend of technical breadth across embedded systems, cloud/SaaS platforms, and manufacturing processes, combined with deep project management discipline in a regulated medical device environment. This individual will serve as the central point of coordination across engineering, quality, regulatory, medical affairs, clinical, manufacturing, and external partners.

Key Responsibilities:

Project Planning and Execution:

• Lead end-to-end project management for all new projects across the full product development lifecycle, from concept through design transfer and commercial release
• Lead end-to-end project management for all sustaining projects across the full product development lifecycle, from concept through design transfer and commercial release
• Develop and maintain integrated project schedules, budgets, resource plans, and risk registers using tools such as Microsoft Project, Jira, or equivalent
• Define project scope, objectives, milestones, deliverables, and success criteria in collaboration with VP of Product Development and functional leads
• Establish and drive project governance cadence including kickoffs, design reviews, sprint planning, stage-gate reviews, and executive status reporting
• Manage project interdependencies across hardware, software, firmware, cloud infrastructure, and manufacturing workstreams

Cross-Functional Team Leadership:

• Coordinate and align cross-functional project teams including software engineering, firmware/hardware engineering, mechanical/industrial design, quality assurance, regulatory affairs, medical affairs, clinical, manufacturing, and supply chain
• Facilitate design control activities in accordance with FDA 21 CFR 820 and ISO 13485, including design inputs, design outputs, design verification/validation (V&V), and design transfer with an end goal of successful 510(k) product clearance on predictable timelines at a regular cadence
• Drive resolution of technical and organizational blockers, escalating appropriately to VP of Product Development when needed
• Lead regular team meetings, stand-ups, and retrospectives; ensure clear ownership, accountability, and communication across all team members.

External Vendor and Consulting Management:

• Manage relationships with external consulting firms, contract engineering houses, contract manufacturers (CMs), and specialized service providers
• Draft and negotiate Statements of Work (SOWs), service agreements, and change orders with external partners
• Monitor vendor deliverables, timelines, quality, and cost; hold external partners accountable to contractual commitments
• Coordinate technology transfer activities between internal R&D teams and external manufacturing/assembly partners
• Evaluate and onboard new vendors as needed to support project requirements across software, hardware, and manufacturing

Software Development Projects:

• Manage software-intensive projects including cloud platform migration, SaaS product development, desktop application releases, and AI/ML pipeline integration
• Understand Agile/Scrum methodologies and work closely with software engineering leads to manage sprint planning, backlog grooming, and release cycles
• Track software deliverables including requirements traceability, code reviews, automated testing, CI/CD pipelines, and FDA software validation (IEC 62304)

Hardware and Firmware Development Projects:

• Oversee hardware development projects including PCB design, enclosure/mechanical design, sensor integration, cable assemblies, and prototype builds
• Coordinate firmware development activities including real-time embedded systems, signal processing algorithms, wireless communication (BLE/Wi-Fi), and hardware abstraction layers
• Manage hardware prototyping, EVT/DVT/PVT build phases, and pilot production runs in collaboration with manufacturing engineering

Manufacturing and Design Transfer:

• Lead design transfer activities from R&D to manufacturing, ensuring manufacturing readiness including tooling, fixturing, test equipment, and process validation (IQ/OQ/PQ)
• Coordinate with manufacturing engineering on BOM management, assembly procedures, work instructions, and production test protocols
• Support supply chain and procurement activities including component sourcing, long-lead item management, and vendor qualification
• Drive manufacturing process improvements and yield optimization in collaboration with quality and manufacturing teams

Regulatory and Quality Compliance:

• Ensure all projects maintain compliance with FDA Design Controls (21 CFR 820), ISO 13485, ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), IEC 62366 (Usability Engineering) and cybersecurity controls.
• Coordinate preparation of Design History File (DHF) documentation and support regulatory submissions (510(k) and LTF where appropriate)
• Partner with Quality Assurance to drive CAPA, NCR, and audit readiness activities related to project deliverables

Reporting and Communication:

• Provide regular project status updates to VP of Product Development and executive leadership, including schedule health, budget tracking, business risk posture, and key decisions needed
• Prepare executive dashboards, project scorecards, and portfolio-level views across all active R&D programs
• Communicate proactively with stakeholders at all levels, translating technical details into business context for leadership visibility

Required Qualifications:

• Bachelor’s degree in Engineering (Electrical, Mechanical, Biomedical, Software, or related field)
• 7 years of project management experience in medical device product development, with demonstrated experience (via 510(k) clearance record) across software, hardware, and manufacturing disciplines
• 5 years of experience managing external vendors, contract engineering firms, or consulting service companies in a technical R&D environment
• Hands-on day-to-day experience in the application of FDA Design Controls (21 CFR 820), ISO 13485, ISO 14971, IEC 62304, IEC 62366 to project deliverables
• Experience supporting FDA 510(k) regulatory submissions i.e. intimate familiarity with content and quality of design documentation needed for successful regulatory clearance
• PMP, PMI-ACP, or equivalent project management certification required; SAFe or Scrum certification a plus
• Proficiency in project management tools (Microsoft Project, Jira, Smartsheet, or equivalent)
• Demonstrated experience managing 4–6 concurrent projects of varying complexity in a fast-paced R&D environment
• Excellent written and verbal communication skills with the ability to present to engineers and well as executive audiences
• Strong interpersonal skills with ability to influence cross-functional teams without direct authority

Preferred Qualifications:

• Experience with cardiac monitoring, ECG/EKG devices, or wearable medical technologies
• Familiarity with cloud platform development (AWS, Azure), SaaS product delivery, and CI/CD workflows
• Experience with embedded firmware development processes and hardware prototyping lifecycles (EVT/DVT/PVT)
• Background in AI/ML product development or data pipeline architecture in a regulated environment
• Experience with contract manufacturing organizations (CMOs) and design transfer for Class II medical devices
• Understanding of Agile at scale frameworks (SAFe, LeSS) and hybrid Agile-Waterfall development models
• Working knowledge of design for manufacturing (DFM), design for test (DFT), and manufacturing process validation
• Experience with international regulatory requirements (EU MDR, Health Canada, PMDA) a plus

Work Environment and Physical Requirements:

• On-site presence required at R&D headquarters with hybrid flexibility (up to 2 days remote per week, subject to project needs)
• Occasional travel (10–20%) to external vendor sites, contract manufacturers, testing labs, and clinical evaluation sites
• Standard office environment
• Ability to lift and carry up to 25 lbs