SUMMARY: This position is responsible for providing support to design assurance throughout the entire product lifecycle, specifically for the Therapy Delivery business unit. Design Assurance Engineers collaborate with the development, manufacturing, and quality teams to ensure that devices are designed in accordance with product requirements, ISO 13485, and 21 CFR 820. They are responsible for developing and maintaining risk management plans, sterilization plans, conducting audits to ensure compliance with DHF requirements, and providing 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 in the role of quality lead
Takes ownership of the risk management file and collaborates with the R&D team to conduct risk assessments for product design and manufacturing processes
Performs risk and impact assessments for design changes to products
Ensures that the DHF clearly documents trace relationships between design inputs and design outputs
Prepares risk management plans, sterilization plans, verification plans, and may also write associated reports
Co-owns, together with the project manager, the processes and documentation for design reviews, DHF content structure, and project phase gate reviews
Collaborates with engineers in troubleshooting test anomalies and resolving development build nonconformances
Reviews and approves development build records
Provides guidance and coaching to junior engineers
RequirementsQUALIFICATIONS:
Bachelor's Degree (BS) in a life science discipline or equivalent education and experience combination.
Minimum of 7 years of experience in medical device development, with a focus on quality assurance/design verification.
Proficiency in working with quality systems as defined in 21 CFR 820 and ISO 13485.
Experience in working on sterile, single-use products, such as catheters and implantable leads.
Knowledge of ISO standards including ISO 10555-1, ISO 11070, ISO 10993-1, and ISO 11135.
Understanding of ISO 14971 and application of risk management techniques in product development.
Demonstrated technical expertise and leadership in quality.
Strong attention to detail, organization, and accuracy.
Excellent written and verbal communication skills, with the ability to communicate effectively across disciplines and organizational structures.
Experience in utilizing quality tools and methodologies such as nonconformance, CAPAs, design issue tracking, and root cause analysis.
Familiarity with statistical software, preferably Minitab.
Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook).
BenefitsNextern 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
Employer paid short-term disability, long-term disability, and basic life and ad&d insurance coverage
