Senior R&D Engineer
$130k - $142.5kGalvanize Therapeutics
About Galvanize Therapeutics Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients. About the role The Senior R&D Engineer, Design will serve as a key contributor to the early-stage design and development of innovative energy delivery devices at Galvanize. This role will focus on the conceptualization, architecture, and detailed design of both the handle and/or distal assembly of energy delivery devices. The engineer will work closely with cross-functional teams to translate clinical needs into novel product concepts, guide the design iteration process through rapid prototyping and benchtop evaluation, and lay the groundwork for future development and commercialization efforts. Key Responsibilities
- Contribute to the early-stage design and development of catheter-based energy delivery devices, with a focus on the handle and distal assembly.
- Translate clinical and user needs into conceptual designs, working from initial sketches to refined functional prototypes
- Contribute to the creation and maintenance of design control deliverables in compliance with relevant regulatory standards (e.g., 21 CFR Part 820, ISO 13485).
- Generate high-quality engineering drawings and 3D CAD models for design concepts, components, and assemblies.
- Collaborate closely with cross-functional partners in R&D, Clinical, Human Factors, Marketing, Quality, and Regulatory to align design intent with user and business needs.
- Rapidly iterate design solutions through hands-on prototyping, bench testing, and evaluation.
- Support feasibility testing and early engineering testing activities to assess functional performance, usability, and design robustness.
- Contribute to risk analyses such as Hazard Analysis and FMEAs during early product definition.
- Identify and troubleshoot design challenges using structured problem-solving methodologies and iterative testing.
- Clearly document design rationale, trade-off decisions, and development progress to support design reviews and formal milestones.
- Prepare and present design concepts, test data, and technical analysis to internal teams and stakeholders.
- Experience developing state-of-the-art ablation devices/systems or similar medical devices (5+ years' Experience with B.S. in Engineering/Science. 3+ years' experience with M.S.).
- Strong proficiency in 3D CAD (e.g., SolidWorks or Creo) for modeling complex assemblies and creating detailed drawings.
- Demonstrated experience in early-stage concept generation, prototyping, and iterative design refinement.
- Hands-on experience with prototyping tools and methods (e.g., 3D printing, machining, laser welding, adhesives, etc.).
- Solid understanding of human factors, ergonomics, and usability considerations in device design.
- Experience with feasibility testing, root cause analysis, and early-stage risk assessments (e.g., DFMEA).
- Effective verbal and written communication skills, including technical documentation and presentation development.
- Collaborative team player with a proactive approach to problem solving and cross-functional interaction.
- Ability to manage multiple design activities concurrently in a fast-paced, milestone-driven environment
Vacancy posted 2 days ago
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