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Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Define system requirements and drive key technical trade-offs (reliability, performance, manufacturability, cost)
- Establish and maintain a clear, integrated design and process development strategy from concept through commercialization
- Lead design reviews and technical decision forums, ensuring they function as decision-making bodies
- Serve as the final technical decision authority when consensus cannot be reached
- Ensure alignment between design intent and process capability early and throughout development
- Drive resolution, including root cause analysis, of design verification and process validation issues through cross-functional teams
- Provide technical leadership to engineers; challenge assumptions, elevate rigor, and improve decision quality
- Provide work direction, technical guidance, coaching and mentorship to R&D engineers.
Requirements
What you’ll need- Bachelor’s degree in Engineering or related technical field required
- 8+ years of medical device experience with catheter-based interventional products
- Demonstrated experience supporting products from concept through commercialization
- Hands-on expertise in catheter fabrication processes (extrusion, reflow, bonding, assembly)
- Strong system-level thinking with demonstrated ability to:
- o Define technical direction in ambiguous environments
- o Make and defend complex trade-off decisions
- o Integrate design and process considerations
- Proven ability to influence cross-functional teams without authority
- Solid understanding of design controls, risk management, and medical device regulations (ISO 13485, 21 CFR 820, EU MDR)
- Demonstrated ability to improve technical rigor, planning quality, and execution discipline within teams.
Benefits
Comp & perks- medical, prescription drug, dental and vision insurance
- flexible spending accounts
- participation in 401(k) savings plan
- various paid time off benefits, such as PTO, short- and long-term disability and parental leave
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
system requirementsdesign reviewsroot cause analysiscatheter fabrication processesextrusionreflowbondingassemblydesign controlsrisk management
Soft Skills
technical leadershipcoachingmentorshipinfluence without authoritydecision-makingcross-functional collaborationproblem-solvingplanning qualityexecution disciplinesystem-level thinking
Certifications
Bachelor’s degree in EngineeringISO 1348521 CFR 820EU MDR
