Test Engineer II
About The Position
As a Test Engineer II, you'll be a pivotal member of the Product Development team, supporting development of innovative Class II medical devices for the treatment of cardiovascular disease. Reporting to the Engineering Manager, the Test Engineer II plays a critical role in the verification and validation of Jupiter products. The Test Engineer II will be responsible for developing and qualifying standard test methods, developing and qualifying test equipment and fixtures, managing and maintaining laboratory assets including test equipment, executing prototype testing, executing design verification and validation testing (V&V), coordinating test execution with test technicians and outside vendors, and generating test protocol and reports in compliance with internal procedures. This role partners closely with product development engineers, manufacturing engineers, test technicians and quality assurance. The role will support testing and verification & validation needs across the organization and will be critical in the successful regulatory approval, commercialization and ongoing sustaining of life saving cardiovascular devices. We're seeking a passionate, high-energy professional who thrives in a medical device startup environment and can deliver on the responsibilities below. This is an in-office role.
Requirements
- B.S. in engineering
- Minimum 3 years of experience in a related role
- Experience with statistical analysis techniques
- Experience with Minitab
- Experience with ASTM and ISO test standards
- 3D CAD experience (On Shape or SolidWorks preferred)
- Fixture design, fabrication, and assembly
- Experience troubleshooting, maintaining and calibrating test equipment
- Experience following Good Laboratory Practice (GLP) and Good Documentation Practice (GDP)
- Strong communication and presentation skills.
- Ability to work independently in a fast-paced environment while managing changing priorities.
- A demonstrated desire to work in a small medical device startup.
- A willingness to work hard, with a driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.
Nice To Haves
- Medical device test experience preferred
- Experience with test method validation preferred
- Experience with laboratory equipment management preferred
- Experience with root cause analysis preferred
Responsibilities
- Design, develop, build and qualify test fixtures as required.
- Design test fixtures in 3D CAD, specify and source off the shelf components, and coordinate fixture fabrication with outside vendors as required.
- Specify and source off the shelf test equipment to meet testing requirements.
- Generate and maintain test fixture documentation in the quality system, including fixture drawings.
- Design, develop and qualify standard test methods (STM) based on design specifications and relevant industry test standards (ASTM, ISO)
- Perform test method validation (Gage R&R) for standard test methods as required.
- Proactively identify test method related verification risks and implement solutions in collaboration with quality and regulatory.
- Generate design verification and validation test protocols and test reports in compliance with SOPs.
- Perform statistical analysis of test data per statistical analysis procedures.
- Execute prototype testing in support of new product development and process development.
- Execute verification and validation testing following good laboratory practices as required in support of regulatory submissions and ongoing product sustaining.
- Perform root cause analysis of test failures related to test equipment and/or test methods.
- Train technicians and engineers on standard test methods and test equipment.
- Remediate and maintain verification test equipment documentation in compliance SOPs.
- Perform installation qualification for test equipment as required.
- Maintain test equipment performance and calibration.
- Maintain STMs in compliance with relevant industry test standards as required (ASTM, ISO)
- Maintain test equipment traceability through laboratory equipment log
- Support implementation of good laboratory practices in test labs.
Benefits
- competitive pay with performance incentives
- equity opportunities
- comprehensive, top of the market medical, dental, and vision coverage
- top tier 401(k) with a best in-class plan design which includes strong employer contributions
- short and long-term disability
- life insurance
- commuter benefits
- wellness support
- healthy paid time off policy
- company holidays
- company-provided lunches
- Thursday socials
- monthly potlucks
- company events
- volunteer opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
