Lead R&D Engineer, Medical Devices & Energy-Delivery

Galvanize; Redwood City (CA); Vor Ort; USD 150.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

Life and disability insurance

401(k)

Flexible PTO

Zusammenfassung

Galvanize is seeking a Staff R&D Engineer to lead development of pulsed-field energy delivery devices for tissue ablation. You will guide complex design, verification, and validation efforts while mentoring junior engineers and coordinating across design assurance, regulatory, and clinical teams.

You will manage Design Control activities, ensure manufacturability, and contribute to risk management through FMEA and related analyses, with limited travel (<20%).

Qualifikationen

• 7+ years in capital equipment development; medical device experience preferred.
• Experience designing sheet metal parts, injection molded parts, and packaging for capital equipment.
• DFMA knowledge and experience developing assembly processes.
• Experience managing engineering requirements, traceability, and Design Control documentation throughout the product development lifecycle.
• Strong knowledge of medical device Design Controls and Risk Management incl. 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience with risk analysis methodologies including FMEA.
• Experience developing and executing Design Verification activities with protocols, data analysis, and reports.
• Strong problem-solving and decision-making skills; ability to work across functions.

Aufgaben

• Lead engineering workstreams within NPD programs for energy-delivery systems from concept through verification and commercialization.
• Lead design and development of complex components and device features with manufacturability and usability in mind.
• Lead Design Control activities including User Needs, Design Inputs/Outputs, Verification strategies, protocols, and traceability.
• Collaborate with Design Assurance to identify, assess, and mitigate product risks and ensure risk controls.
• Develop and execute Design Verification activities with test strategies, criteria, and data analysis.
• Mentor engineers and drive rigorous engineering practices and cross-functional collaboration.

Kenntnisse

Capital equipment

Medical devices

Sheet metal design

Injection molded parts

DFMA

Design controls

Risk management

FMEA

Design verification

Mentoring

CAD SolidWorks

Cross-functional

Ausbildung

Mechanical or Biomedical Engineering

Tools

SolidWorks

MS Office

Jobbeschreibung

Galvanize is seeking a Staff R&D Engineer to lead development of pulsed-field energy delivery devices for tissue ablation. You will guide complex design, verification, and validation efforts while mentoring junior engineers and coordinating across design assurance, regulatory, and clinical teams.

You will manage Design Control activities, ensure manufacturability, and contribute to risk management through FMEA and related analyses, with limited travel (<20%).