Galvanizetherapeutics
Principal R&D Engineer
Redwood City, CA · Principal · Full-time
Sponsorship not specifiedDetected 26 days ago
Product StrategyIntellectual PropertySolidWorksCreoClinical TrialsMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringTolerance Analysis
About the role
- Other degrees within the engineering discipline are acceptable with medical device experience.
- Recognized technical expert in energy-based catheter or electrosurgical systems, with demonstrated leadership in bringing products from concept through commercialization.
Responsibilities
- 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.
- 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.
Requirements
- Scientific degree in Mechanical or Biomedical Engineering with consideration given to degree level combined with experience.
- Advanced proficiency in 3D CAD (e.g., SolidWorks or Creo) for complex assemblies, tolerance stack-ups, and design documentation under regulated design control processes.
- Deep, hands-on knowledge of prototyping methods and materials, including 3D printing, machining, laser processing, bonding, and assembly of catheter-based systems.
Skills
- Experienced in leading and mentoring cross-functional teams, fostering a culture of technical excellence and innovation.
Compensation
- This 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 Therapeutics is an Equal Employment Opportunity Employer.
- We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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