Senior Sustaining R&D Engineer – Medical Devices

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.

• 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.

• 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.

• 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.