Nextern is hiring for the role of Senior Design Assurance Engineer - Therapy Delivery. This roles comes with competitive pay and a full benefits package (details below)
SUMMARY: The role of Senior Design Assurance Engineer is responsible for supporting design assurance throughout the product lifecycle, specific to the Therapy Delivery business unit. Design Assurance Engineers work with the development, manufacturing, and quality team to ensure devices are designed in accordance with product requirements, ISO 13485, and 21 CFR 820. They develop and maintain risk management plans, sterilization plans, audit against the requirements for the DHF, and provide feedback on product requirements, risk assessments, and verification methods.
DUTIES AND RESPONSIBILITIES:
?? Guides the design control process for product development projects
?? Reviews, provides feedback, and approves project design and development deliverables as the quality lead
?? Owns the risk management file and works with the R&D team to perform risk assessment for product design and manufacturing processes
?? Performs risk and impact assessments for design changes to products. s
?? Assures that the DHF clearly documents the trace relationships between design inputs and design outputs
?? Writes risk management plans, sterilization plans, verification plans, and may author associated reports.
?? Co-owns, with the project manager, the processes and documentation for design reviews, DHF content structure, and project phase gate reviews.
?? Collaborate with engineers on troubleshooting test anomalies and development build nonconformances.
?? Review and approve development build records.
?? Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
?? 5+ years of experience in medical device development, with experience primarily in quality assurance/design verification.
?? Experience working in quality systems as defined in 21 CFR 820 and ISO 13485
?? Experience working on sterile, single-use products such as catheters and implantable leads.
?? Experience working within the requirements of: ISO (phone number removed), ISO 11070, ISO (phone number removed), ISO 11135.
?? Understanding of ISO 14971 and application of risk management techniques to product development.
?? Demonstrated technical expertise and leadership in quality
?? High attention to detail, organization, and accuracy.
?? Strong ability to communicate (written and verbally) within and across disciplines and organization structures
?? Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, design issue tracking, root cause analysis)
?? Familiarity with statistical software, such as Minitab, preferred.
?? Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook)
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!
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!