About the role
- Lead the planning and execution of medical device product development and commercialization projects from concept through launch.
- Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.
- Develop and maintain detailed project plans, timelines, resource allocations, and budgets.
- Ensure alignment between project goals and organizational strategy through effective stakeholder management.
- Serve as the primary liaison among R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.
- Manage change control processes and ensure that design and process changes are properly evaluated, documented, and approved.
- Identify potential project risks and mitigation strategies, maintaining proactive issue resolution throughout the project lifecycle.
Requirements
- 5+ years of experience in a regulated medical device, biotechnology, or pharmaceutical environment
- Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a related field
- Proven experience managing projects in a regulated medical device, biotechnology, or pharmaceutical environment
- Strong understanding of product development processes, design control, and risk management (ISO 14971)
- Proficiency with project management tools such as MS Project, Smartsheet, or equivalent.
- Excellent communication, documentation, and stakeholder management skills.
- Strong problem-solving, analytical, and organizational abilities.
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementproduct developmentdesign controlrisk managementchange controlbudget managementresource allocationtimelines managementstakeholder managementissue resolution
Soft skills
communicationdocumentationproblem-solvinganalyticalorganizational