The 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
Leads the design control process for product development projects
Authors, 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.
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.
Provides guidance and coaching to junior engineers.
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)
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
IT Services and IT Consulting
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