Sr. Design Assurance & Quality Engineer

Sr. Design Assurance & Quality Engineer Magvation Inc. San Diego, CA Job Details Full-time $130,000 - $170,000 a year 3 hours ago Benefits Stock options Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance Life insurance Paid sick time Qualifications Content creation for technical audiences Technical documentation ISO standards Quality control statistical data analysis Engineering Statistical Process Control Technical writing within manufacturing Quality assurance within IT Minitab Collaboration with product development teams Bachelor's degree in engineering Production validation processes Quality risk management Attention to detail Supply chain management Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Computer skills Mechanical product validation projects Cross-functional communication Supplier quality assurance (SQA) FDA regulations Data analysis software Full Job Description Company Overview Magvation is a dynamic and innovative MedTech company committed to reducing disruption in the operating room by modernizing outdated processes, improving workflow visibility, and advancing technology solutions that improve surgical safety. As a late-stage startup with commercialization imminent, Magvation is building the systems, tools, and team infrastructure necessary to transform clinical insight, workflow data, and intelligent technology into measurable value for customers. Job Summary We are seeking a skilled Medical Device Design Assurance and QualityEngineerto lead key design control activities and provide ongoing support as we launch and scale manufacturing of the Magvation Smart Surgical Safety System. This is Full-Time, on-site position located in San Diego (92127) and provides Magvation's standard benefits including stock options, medical, dental and vision insurance, Paid Time Off, Paid Sick Leave, a 401(k) Plan, and other voluntary offerings. Key Responsibilities Lead quality and reliability support for the development of the hardware, software and system comprising the Smart Surgical Safety System, providing hands-on support for both production operations and product development initiatives. Own and manage risk management documentation, including reliability, risk and hazard analyses, including Failure Modes and Effects Analyses (FMEAs). Provide quality leadership by authoring, reviewing, and approving design and development verification and validation protocols, and reports for hardware, software, and system. Provide statistical analysis and sample size justification to support production and development qualification and validation testing. Plan, coordinate, and oversee supplier and component selection and qualification, ensuring reliable and compliant supply chains. Develop, review, and approve test plans and test reports supporting production testing, screening activities, and qualification efforts. Lead investigations into returned products, field issues, complaints, and clinical adverse events, perform root cause analysis, health hazard evaluations, and support CAPA activities with thorough documentation. Generate, review, and approve Nonconforming Material Reports (NMRs), deviations, product holds, and issue documentation, ensuring effective quality and reliability support for manufacturing operations. Drive continuous improvement in product quality and reliability by identifying and implementing process enhancements and product design improvements. Qualifications Bachelor's degree in Engineering (Mechanical, Biomedical, or closely related field). 5+ years of experience in design assurance and quality engineering within the medical device industry, preferably in a start-up environment. Subject Matter Expertise in Medical Device Design Controls Risk Management, Verification and Validation and Supplier Qualification across both hardware and software. Familiarity with SPC, Gage R&R and DOE methodologies. Familiarity with FDA regulations and quality standards, 21 CFR part 820, ISO 13485, ISO 14971, and

ISO 60601.

Excellent problem-solving skills, critical thinking, and attention to detail. Ability to work cross-functionally with Manufacturing, R D, Regulatory and Commercial teams. Self-motivated with strong written and verbal communication skills, and proficiency in technical writing. Computer skills including Microsoft 365, project management software (e.g., Smartsheet, MS Project), eQMS platforms (e.g., Greenlight Guru, Veeva Vault), and statistics software (e.g., Minitab). Preferred Skills Experience bringing sterile, electro-mechanical, Operating Room-based medical device products to market. Expertise and experience in Cybersecurity and Human Factors/Usability Engineering. Knowledge of sterilization processes, biocompatibility standards and 60601/NRTL requirements. Experience in Project Management and associated tools.

Pay:

$130,000.00 - $170,000.00 per year

Benefits:

401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Application Question(s): Are you authorized to work in the United States for any employer?

Work Location:

In person