Principal Engineer, Design Dev, R&D

Position Summary

The Principal R&D Engineer serves as the technical lead for a product development program, with accountability for system-level design, cross-functional integration, and manufacturing readiness. This individual establishes technical direction, drives alignment between design and process development, and ensures decisions are made with clarity, rigor, and speed.

Principal Responsibilities

•    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.

Education / Experience Requirements

•    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

Specialized Skills / Other Requirements

•    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

The pay range for this position at commencement of employment is expected to be between $152,800 - $229,200, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 10 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory