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.
...