Scientific/Research: Bellevue, WA

Job Title

R&D Project Manager – Medical Device Development

Location

Washington (On-Site/Hybrid)

Hours

Full-Time, 36 hours per week

Pay Range

$115,000.00–$150,000.00 per year

Benefits include; Medical, Dental, Vision, 401(k), Weekly direct deposit and more

General Job Duties

• Manage multiple medical device development projects from concept through product launch

• Lead cross-functional teams across engineering, quality, regulatory, manufacturing, and clinical departments

• Develop and maintain project schedules, budgets, timelines, and risk plans

• Coordinate software, hardware, firmware, and manufacturing activities

• Support FDA 510(k) submissions and design control documentation

Required Skills and Experience

• Bachelor’s Degree in Engineering (required)

• 7+ years of medical device project management experience

• Experience supporting FDA 510(k) submissions and regulated product development

• Knowledge of FDA Design Controls, ISO 13485, ISO 14971, and IEC 62304

• Experience managing multiple concurrent projects and cross-functional teams

• Proficiency with Microsoft Project, Jira, or similar project management tools

Licensure and Certifications Required

• PMP, PMI-ACP, or equivalent Project Management Certification

Preferred Qualifications

• Experience with cardiac monitoring, ECG/EKG, or wearable medical devices

• Knowledge of AWS, Azure, SaaS platforms, or embedded systems

• Experience with contract manufacturers and Class II medical devices

• Familiarity with Agile/Scrum methodologies and design transfer processes