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About the role
Key responsibilities & impact- Lead high-impact medical device development projects across hardware, systems, and consumables from concept through commercialization
- Align and lead cross-functional teams across Engineering, Quality, Regulatory, Operations, Marketing, and external partners to deliver integrated project outcomes on time and to standard
- Develop and continuously refine integrated project plans, proactively managing scope, schedule, resources, dependencies, and critical path
- Proactively identify, assess, and mitigate project risks, prioritizing actions based on business impact
- Facilitate structured, data-driven problem solving for complex technical and organizational challenges
- Own alignment of projects with evolving business priorities, customer needs, and applicable regulatory and quality system requirements
- Own executive-level communication, influence cross-functional alignment, resolve trade-offs, and maintain momentum across projects
- Promote a collaborative, high-performance environment that encourages innovation and shared accountability
Requirements
What you’ll need- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required
- 3+ years of project management experience leading end-to-end product development and commercialization of regulated products
- 2+ years in the Medical Device industry, including hands-on experience leading projects that resulted in FDA 510(k) clearance
- Working knowledge of 21 CFR 820 and ISO 13485
- Demonstrated ability to lead medium to large, global, and interdependent projects in technical domains
- Hands-on experience with process improvement and metrics, including use of tools like Jira, Confluence, and Fortive Business Systems (FBS)
- Track record of mentoring and developing high-performing project teams
Benefits
Comp & perks- Proactively support ASP’s Environmental, Health and Safety (EHS) Policy
- Provide necessary resources and give equal emphasis with other functions
- Ensure implementation of safety and environmental procedures, guidelines and standards
- Evaluate employee compliance and enforce established safety and environmental procedures and rules
- Create a safe work area environment, recognize safe activities, and reward good safety performance
- Provide training to employees when needed
- Measure safety performance and hold persons accountable for activities and results
- Ensure that incidents are investigated to determine root cause, and that corrective actions are taken
- Ensure employees wear required protective equipment
- Ensure EHS inspections are conducted monthly and corrective actions are implemented
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementproduct developmentcommercializationrisk managementprocess improvementmetrics
Soft Skills
leadershipcommunicationcollaborationproblem solvinginfluence
