Job Information
Actalent R&D Systems Engineer in Santa Clara, California
Description:
The R&D Test Engineer, Systems will use technical skills in the test and characterization of various electro-mechanical elements for the clients medical device . The R&D Test Engineer, Systems will work with cross-functional development teams to test, characterize and verify IVL devices; engage in specification refinement; execute testing; and provide support to other departments as required.
Essential Job Functions
Hands on system testing to generate evidence of system function and performance.
Utilize Oscilloscopes, digital multimeters, force gauges, general metrology equipment, calibration records(s) and documentation in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD criteria.
Develop, refine, and evaluate test methods based on product requirements and lower-level design specifications to create formal protocols for test.
Participate on cross-functional development teams that manage projects from concept through commercialization.
Ensure lab notebooks are documented in a timely manner and consistent with the applicable SOP.
Develop protocols/reports and perform product in-vitro, verification and validation testing.
Troubleshooting electro-mechanical systems and accessories.
Good written and verbal communication skills, including interfacing with external suppliers.
Provide support to operations and regulatory initiatives as required.
Skills:
electromechanical devices, oscilloscope, digital volt meter, electrical circuit, function generator
Additional Skills & Qualifications:
Requirements
Bachelor’s degree in electrical, systems, mechanical engineering or equivalent with 3+ years of product development experience, or a master’s degree with 2+ years of product development experience.
Familiarity with various test methods within the medical device environment such as Gauge R&R, statistical testing, system characterization, verification, etc.
Familiarity with risk management processes and applications.
Experience in protocol writing, data collection and management, and report writing.
Engineering experience in the medical device industry.
Experience integration and verification testing.
Ability to work in a fast-paced environment, managing multiple priorities.
Experience with JAMA is a plus.
Employee may be required to lift objects up to 25lbs.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.