About the roleThe Principal R&D Engineer, Design, is a technical leader responsible for driving the conception, development, and advancement of innovative medical device designs. This role sets design strategy, leads complex product development efforts, and champions best-in-class engineering practices across multiple programs. As a recognized expert in product design, the Principal Engineer brings deep technical insight, influences cross-functional direction, and ensures alignment between engineering execution, clinical needs, and business objectives.
QualificationsEducation and Training: Scientific degree in Mechanical or Biomedical Engineering with consideration given to degree level combined with experience. Other degrees within the engineering discipline are acceptable with medical device experience.
Skills and Experience:- 10+ years of progressive experience in the design and development of complex Class II/III medical devices, preferably in ablation or energy delivery systems.
- Recognized technical expert in energy-based catheter or electrosurgical systems, with demonstrated leadership in bringing products from concept through commercialization.
- Advanced proficiency in 3D CAD (e.g., SolidWorks or Creo) for complex assemblies, tolerance stack-ups, and design documentation under regulated design control processes.
- Extensive experience in early-stage innovation, including concept generation, prototyping, feasibility evaluation, and iterative design refinement.
- Deep, hands-on knowledge of prototyping methods and materials, including 3D printing, machining, laser processing, bonding, and assembly of catheter-based systems.
- Strong understanding of human factors, usability engineering, and ergonomic design principles, particularly in minimally invasive surgical applications.
- Proven ability to lead feasibility testing, root cause analysis, and comprehensive risk management activities, including DFMEA and hazard analysis.
- Excellent technical communication and documentation skills, with a track record of authoring design rationales, test plans, and regulatory submissions.
- Experienced in leading and mentoring cross-functional teams, fostering a culture of technical excellence and innovation.
- Highly effective in managing multiple complex workstreams in fast-paced, milestone-driven environments, with strong systems thinking and prioritization skills.
- Demonstrated ability to influence product strategy and design direction, aligning engineering decisions with business objectives and clinical needs.
Other: Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.
What you'll do- Lead the design and development of catheter-based, single-use electrosurgical devices, with a primary focus on the handle and distal assembly, ensuring optimal performance, manufacturability, and clinical usability.
- Translate clinical needs into system-level product architectures, guiding concept development and ensuring alignment between user requirements, functional performance, and design constraints.
- Define and drive technical design strategy, establishing best practices for energy delivery mechanisms, safety-critical features, and integration of multi-disciplinary components (e.g., thermal, electrical, mechanical).
- Oversee and review design control documentation, ensuring full compliance with regulatory standards (e.g., 21 CFR Part 820, ISO 13485) and proactively identifying potential gaps.
- Provide technical leadership for CAD design and drawing quality, including tolerance analysis, DFM/DFA best practices, and configuration control.
- Mentor and review work of junior and senior engineers in concept development, design execution, prototyping, and testing.
- Lead cross-functional collaboration with Clinical, Human Factors, Marketing, Quality, Regulatory, and External Contract Manufacturers to translate complex requirements into robust design solutions.
- Direct and oversee rapid prototyping, bench testing, and iterative design cycles, setting technical goals and interpreting results to inform next steps.
- Guide feasibility and verification testing strategies, ensuring early identification of risks and validation of critical performance metrics.
- Lead and contribute to risk management activities (e.g., Hazard Analysis, FMEAs), ensuring comprehensive mitigation plans are in place for energy delivery systems.
- Drive root cause analysis and structured problem-solving, leveraging data-driven approaches to resolve complex design issues.
- Present technical strategies, trade-off analyses, and development plans to executive stakeholders, design review boards, and external partners.
- Contribute to intellectual property development, identifying opportunities for innovation and supporting patent filings.
Compensation & BenefitsThis role pays between $175,000 and $200,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience. Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.
