Nextern is hiring for the role of Design Assurance Engineer - Therapy Delivery. This roles comes with competitive pay and a full benefits package (details below)
The Design Assurance Engineer will be responsible for supporting design verification activities throughout the product lifecycle, specific to the Therapy Delivery business unit. Design Assurance Test Engineers work with the development, manufacturing, and quality team to ensure devices are designed in accordance with product requirements. They develop and maintain verification test procedures, test method validation procedures, and equipment qualifications.
DUTIES AND RESPONSIBILITIES:
Translate design requirements into verification test procedures.
Develop and maintain design verification test procedures, test method validation procedures, and equipment qualifications.
Maintain trace matrices that document tracing among risks, requirements, and test procedures.
Evaluate testability of requirements and provide requirements feedback to design engineers.
Design and build test fixturing for mechanical test cases.
Assist in the execution of design verification testing.
Document test results, measurement detail, and test anomalies throughout the verification test process.
Analyze test anomalies and create test summary and report style technical documents.
Collaborate with engineers on troubleshooting test anomalies.
Create and update verification test procedures in accordance with applicable design changes.
Review and approve development build record
Working at Nextern is a better kind of work. We look for people who can exercise their personal superpowers while living our company principles. At Nextern, we are all responsible for making a meaningful impact on day to day patient quality of life. Our unique energy is unmistakable as we have fun, care about one another, and build a place we can all grow & produce great work. Come join Nextern, where we are in it TOGETHER!
Bachelor's Degree (BS) in S.T.E.M. Mechanical engineering or a related discipline preferred.
2+ years of experience in medical device development
Basic understanding of the design verification process and good documentation practices (GDP),
Understanding of statistical techniques for establishing confidence and reliability intervals.
Computer skills required: Spreadsheet Software (Excel); Word Processing Software (Word); Electronic Mail Software (Outlook); Presentation software (PowerPoint), CAD modeling software, such as Solidworks.
Other skills required: Technical understanding of mechanical engineering principals and procedures. Ability to use laboratory equipment (tensile tester, CMMs, 3D printer etc.).
Nextern offers excellent benefits to fuel you in building a fulfilling life & career: Employer subsidized health insurance for employees
Employer paid dental insurance
Employer HSA contribution
401k plan with a company match
9 paid holidays (including your birthday!) + vacation, personal and sick days
Gym membership subsidy
Employee Long Term Disability, AD&D, and Life Insurance
Modern facilities with lots of natural light, and occasionally, tacos, because these things are important to productivity!