Staff R&D Engineer, Mechanical

Galvanize•Redwood City, CA

11d•$150,000 - $170,000

About The Position

The Staff R&D Engineer will lead technical development of pulsed-field energy delivery electrosurgical devices, contributing to complex design and development projects and overseeing product verification and validation activities. The role provides technical leadership for assigned engineering workstreams from concept development through verification and commercialization, and mentors engineers to support high-quality outcomes and alignment with project goals. The position develops complex components, sub-assemblies, and device features by translating product and clinical requirements into engineering solutions that address performance, safety, manufacturability, and usability. It leads Design Control activities, risk-management efforts, and verification planning and execution, and collaborates with cross-functional teams on product and program objectives. The engineer also supports design transfer, manufacturing readiness, design changes, sustaining activities, and complaint investigations. Domestic and international travel of less than 20% may be required to collaborate with external vendors and support clinical trials. The stated annual salary range is $150,000 to $170,000, with actual base pay depending on location, skills, qualifications, and experience.

Requirements

Scientific degree in Mechanical or Biomedical Engineering; degree level may be considered in combination with experience. Other engineering degrees are acceptable with medical device experience.
At least 7 years of experience developing capital equipment.
Experience designing sheet metal parts, injection-molded parts, and packaging for capital equipment.
Strong knowledge of Design for Manufacturing and Assembly and experience developing assembly processes.
Experience developing and managing engineering requirements, traceability, and Design Control documentation throughout the product development lifecycle.
Strong knowledge of medical device Design Controls and Risk Management, including 21 CFR Part 820, ISO 13485, and ISO 14971.
Experience with risk analysis methodologies, including FMEA and other applicable design- and use-related risk assessments.
Experience developing and executing Design Verification activities, including test protocols, acceptance criteria, data analysis, and technical reports.
Strong technical problem-solving and decision-making skills, including evaluating trade-offs and resolving complex engineering challenges.
Excellent communication, collaboration, and organizational skills, including the ability to manage multiple priorities and work effectively across functions.
Experience with CAD/design and engineering testing tools.
Proficiency with Microsoft Office and technical documentation tools.
Ability to mentor engineers and influence cross-functional teams while working independently and with limited direction.
Ability to travel domestically and internationally less than 20% when necessary.

Nice To Haves

Medical device development experience is preferred.
Experience with SolidWorks is preferred.

Responsibilities

Lead assigned engineering workstreams in new product development programs for tissue-ablation energy-delivery systems, from concept development through verification and commercialization.
Lead design and development of complex components, sub-assemblies, and device features, translating product and clinical requirements into solutions that consider performance, safety, manufacturability, and usability.
Lead Design Control activities for assigned technical areas, including User Needs, Design Inputs and Outputs, verification strategies, protocols, reports, and requirements traceability.
Partner with Design Assurance to identify, assess, and mitigate product risks, provide engineering input to risk assessments, and ensure risk controls are incorporated into the design and verified.
Develop and execute Design Verification activities, including test strategy, methods, acceptance criteria, protocols, testing, data analysis, and reporting.
Lead technical design, risk, and test reviews; evaluate trade-offs, resolve design challenges, and drive timely decisions.
Collaborate with Principal Engineers, Engineering Managers, Design Assurance, Regulatory, Clinical, and other R&D functions to develop engineering solutions and maintain alignment with product and program objectives.
Partner with Process Development Engineering on Design Transfer and manufacturing readiness, considering manufacturability, assembly, process requirements, and production needs.
Provide engineering support for design changes, sustaining activities, and complaint investigations.
Serve as a technical resource and mentor to engineers, promote rigorous engineering practices and continuous improvement, and communicate technical information to technical and non-technical stakeholders.
Travel domestically and internationally, less than 20%, to collaborate with external vendors and support clinical trials when necessary.