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Actalent · 2 days ago
R&D Systems Engineer
Santa Clara, CA
Contract
Onsite
Mid Level
3+ years exp
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Responsibilities
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.
Qualification
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Required
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
Preferred
Experience with JAMA is a plus
Employee may be required to lift objects up to 25lbs
Benefits
Health Insurance
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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