Staff R&D Engineer, Mechanical

About the role

The Staff R&D Engineer will lead and drive the development of innovative pulsed-field energy delivery electrosurgical devices. This role involves spearheading technical contributions to complex design and development projects, overseeing the execution of comprehensive product verification and validation testing, and mentoring junior engineers to ensure high-quality outcomes and alignment with project goals.

Qualifications

Education and Training

• Scientific degree in Mechanical or Biomedical Engineering with consideration given to degree level combined with experience. Other degrees within the engineering discipline are acceptable with medical device experience.

Skills and Experience

• 7+ years of experience developing capital equipment; experience with 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 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, with the ability to evaluate trade-offs and resolve complex engineering challenges.
• Excellent communication, collaboration, and organizational skills, with the ability to manage multiple priorities and work effectively across functions.
• Experience with CAD/design and engineering testing tools, experience with SolidWorks is preferred; proficiency with Microsoft Office and technical documentation tools.
• Ability to mentor engineers and influence cross-functional teams while working independently and with limited direction.

Other

• Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.

What you'll do

• Lead assigned engineering workstreams within NPD programs for energy-delivery systems for tissue ablation, providing technical leadership from concept development through verification and commercialization.
• Lead the design and development of complex components, sub-assemblies, and device features, translating product and clinical requirements into robust engineering solutions while considering performance, safety, manufacturability, and usability.
• Lead Design Control activities for assigned technical areas, including User Needs, Design Inputs and Outputs, Design Verification strategies, protocols, reports, and requirements traceability, ensuring alignment with product requirements and overall development strategy.
• Partner with Design Assurance to identify, assess, and mitigate product risks in accordance with applicable risk-management requirements, providing engineering input to risk assessments and ensuring appropriate risk controls are incorporated into the design and verified.
• Develop and execute Design Verification activities for assigned technical areas, including test strategy, methods, acceptance criteria, protocols, execution, data analysis, and reporting to demonstrate that product requirements and risk controls have been adequately verified.
• Lead technical design, risk, and test reviews, apply engineering judgment to evaluate technical trade-offs, resolve complex design challenges, and drive timely decisions within assigned areas.
• Collaborate with Principal Engineers, Engineering Managers, and cross-functional teams including Design Assurance, Regulatory, Clinical, and other R&D functions to develop effective engineering solutions and maintain alignment with product and program objectives.
• Partner with Process Development Engineering to support Design Transfer and manufacturing readiness, ensuring design outputs consider 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 other engineers, promoting rigorous engineering practices, structured problem-solving, innovation, and continuous improvement while effectively communicating complex technical information to technical and non-technical stakeholders.

Pay and benefits

This role pays between $150,000 and $170,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.