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Nextern is hiring for the role Sr. Design Assurance Engineer(link removed) This role comes with competitive pay and a full benefits package (details below)
The Sr. 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. Sets strategies and drives towards compliant and efficient solutions to complex problems.
Responsible for Design Verification and Validation planning & execution.
Leads root-cause investigations and resolution activities.
Reviews, provides feedback, and approves project design and development deliverables as the quality lead.
Leads Risk Management and Usability program activities from product Concept through Commercialization.
Performs risk and impact assessments for design changes to products.
Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
Support design test and inspection method development, and lead method validation activities.
Writes risk management plans, design verification and validation plans, and may author associated reports.
Co-owns, with the project manager, the processes and documentation for design reviews, DHF content structure, and project Design Reviews.
Review and approve development build records.
Requirements
QUALIFICATIONS:
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 10555-1, ISO 11070, ISO 10993-1, 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)
Benefits
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!) + PTO and Personal days
- Gym membership subsidy
- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance
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