Senior R&D Engineer – Pulsed Field Medical Devices

Galvanize Therapeutics; Redwood City (CA); Hybrid; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k)

Paid time off

Job summary

Galvanize Therapeutics seeks a Staff R&D Engineer to lead the development of pulsed-field energy delivery electrosurgical devices from concept through verification and commercialization.

You will mentor junior engineers, oversee comprehensive product verification and validation testing, and collaborate with cross-functional teams to ensure high-quality outcomes aligned with project goals.

Qualifications

• Scientific degree in Mechanical or Biomedical Engineering with consideration given to degree level combined with experience.
• Experience with capital equipment and medical devices is preferred.
• Experience designing sheet metal parts, injection molded parts, and packaging for capital equipment.
• Strong knowledge of Design for Manufacturing and Assembly and developing assembly processes.
• Experience developing engineering requirements, traceability, and Design Control documentation.
• Strong knowledge of medical device Design Controls and Risk Management (21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with risk analysis methodologies (FMEA).
• Experience developing and executing Design Verification activities with protocols and data analysis.
• Excellent communication and collaboration across functions.

Responsibilities

• Lead assigned engineering workstreams within NPD programs for energy-delivery systems for tissue ablation.
• Lead the design and development of complex components, sub-assemblies, and device features from concept to verification and commercialization.
• Lead Design Control activities including User Needs, Design Inputs/Outputs, Verification strategies, and requirements traceability.
• Partner with Design Assurance to identify, assess, and mitigate product risks and ensure risk controls are implemented.
• Develop and execute Design Verification activities with test strategies, criteria, and data analysis.
• Lead technical reviews and collaborate with cross-functional teams to maintain alignment with objectives.
• Support Design Transfer and manufacturing readiness, considering manufacturability and production needs.
• Mentor engineers and promote rigorous engineering practices and problem-solving.

Skills

Sheet metal design

Injection molded parts

Design for Manufacturing and Assembly

Engineering requirements & Design Data

Medical device Design Controls & Risk

FMEA & risk assessments

Design Verification & testing

Cross-functional collaboration

Technical documentation practices

Education

Bachelor’s or higher in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

Galvanize Therapeutics seeks a Staff R&D Engineer to lead the development of pulsed-field energy delivery electrosurgical devices from concept through verification and commercialization.

You will mentor junior engineers, oversee comprehensive product verification and validation testing, and collaborate with cross-functional teams to ensure high-quality outcomes aligned with project goals.