Senior Sustaining R&D Engineer – Medical Devices

Hydrogen UK Ltd; Irvine (CA); On-site; USD 71,000 - 118,000; Full time

Job summary

Hydrogen UK Ltd. seeks a Senior Sustaining R&D Engineer to support existing medical device products in Irvine, CA.

This role emphasizes hands-on testing, verification, and comprehensive documentation within a cross-functional team including Quality, Manufacturing, Clinical, and Regulatory groups. The successful candidate will bring advanced engineering knowledge, strong analytical skills and the ability to translate complex data into actionable recommendations and design-control documentation

Qualifications

• Bachelor's degree in Engineering or a Scientific field with 5+ years of relevant experience.
• Master's degree in Engineering or a Scientific field with 4+ years of relevant experience.
• Strong engineering knowledge and understanding of engineering principles.

Responsibilities

• Support existing commercialized products in a cross-functional R&D environment.
• Partner with Quality, Manufacturing, Clinical and Regulatory teams on sustaining activities.
• Develop complex experiments and tests to evaluate and improve products.
• Write and execute engineering test protocols, especially for design verification.
• Analyze test results and provide engineering recommendations.
• Prepare technical reports and supporting documentation.
• Generate and maintain work instructions, drawings and prototypes.
• Establish and characterize product and process specifications.
• Create and update design control documentation and risk documentation.
• Develop and execute engineering project plans.
• Coordinate technical work performed by technicians.

Education

Bachelor's degree in Engineering or a Scientific field

Master's degree in Engineering or a Scientific field

Tools

CAD

Minitab

Job description

Senior Sustaining R&D Engineer – Medical Devices

Location: Irvine, CA
Contract: 12 Months
Schedule: Standard
Pay Rate: Up to $56.81 per hour

We are seeking an experienced Senior Sustaining R&D Engineer to support existing commercialized products within a medical device environment.

This position will work cross-functionally with Quality, Manufacturing, Clinical and Regulatory teams, with a strong focus on device testing, design verification, technical justification, design controls and engineering documentation.

The successful candidate will bring strong engineering fundamentals, hands-on testing experience and the ability to analyze complex technical information and translate findings into clear engineering recommendations and documentation.

Key Responsibilities

• Support existing commercialized products in a cross-functional R&D environment.

• Partner with Quality, Manufacturing, Clinical and Regulatory teams on sustaining engineering activities.

• Develop complex experiments and engineering tests to evaluate and improve products.

• Write and execute engineering test protocols, particularly for design verification activities.

• Analyze test results, develop technical conclusions and make engineering recommendations.

• Prepare technical reports and supporting documentation based on engineering findings.

• Generate and maintain work instructions, test methods, engineering models, drawings and prototypes.

• Establish and characterize product and process specifications.

• Create and update design control documentation, including requirement specifications and risk documentation.

• Develop and execute engineering project plans.

• Evaluate technical information and develop recommendations involving parts, components and subsystems.

• Review historical technical documentation to identify gaps and determine whether existing evidence can support technical justifications.

• Support supplier activities, including establishing tolerances and defining acceptance criteria.

• Evaluate and provide technical guidance to suppliers as required.

• Coordinate R&D support activities performed by technicians.

• Provide technicians with instructions for testing, training and technical feedback.

• Perform other related engineering duties as assigned.

Qualifications

• Bachelor's degree in Engineering or a Scientific field with 5+ years of relevant experience, OR

• Master's degree in Engineering or a Scientific field with 4+ years of relevant experience.

• Strong engineering knowledge and understanding of relevant engineering principles, theories and concepts.

• Experience developing and executing engineering tests and protocols.

• Strong technical documentation and report-writing skills.

• Ability to read and interpret technical drawings, schematics and computer-generated reports.

• Strong analytical, critical-thinking and problem-solving skills.

• Excellent organizational skills and strict attention to detail.

• Strong written and verbal communication skills.

• Ability to manage competing priorities within a fast-paced environment.

• Ability to work effectively across multidisciplinary and interdepartmental teams.

Preferred Experience

• Medical device industry experience is highly preferred.

• Experience supporting sustaining R&D or existing commercialized medical devices.

• Knowledge of design verification and design control documentation.

• Knowledge of materials and manufacturing processes used in catheter construction.

• Experience developing test methods and working with laboratory or industrial equipment.

• CAD experience.

• Minitab experience.

• Basic understanding of statistical techniques.

• Experience working with suppliers, including tolerances and acceptance criteria.

• Experience coordinating technical work performed by engineering technicians.

• Strong proficiency with Microsoft Office applications.

This position requires an engineer who can combine hands-on technical testing with strong documentation and cross-functional collaboration to support the continued performance and quality of commercialized products.