The Lead Design Assurance Engineer is responsible for following established GMP/ISO compliant quality system practices.
Duties:
Lead design assurance activities in support of development for risk management files (Hazard Analysis, FMEA, Risk management Planning, Risk Management Report, Benefit Risk Analysis) per ISO 14971 guidelines.
Manage new risk management file.
Work with Engineering, Marketing, Manufacturing and Regulatory to establish risk management files.
Understand test plan protocols, test procedures, and test reports used for risk controls.
Understand design verification and design validation plans and links to the risk management files.
Understand implication of risk management in Verification and Validation sampling plans.
Able to lead technical discussions of products and associated risk management documentation.
Qualifications:
Bachelor’s or Master’s degree and minimum 5+ years’ experience in Medical Device Design Assurance / Quality Engineer roles with deep hands-on ISO 14971 risk management experience, including ownership of Risk Management Files, FMEA/Hazard Analysis and strong understanding of Design Controls and V&V.
Strong understanding of how risk management integrates into the medical-device development lifecycle: Design Controls → Risk Analysis → Risk Controls → Design Inputs/Outputs → Verification & Validation → Traceability.
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Numbers & Facts
Location
Pleasanton, CA
Industry
Staffing/Employment Agencies
Company Size
500 to 999 employees
Website
https://www.thefountaingroup.com/
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
Compensation and Benefitsunmatched
Design Verificationunmatched
Documentationunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
GMP (Good Manufacturing Practices)unmatched
Hazard Analysisunmatched
Health Insuranceunmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Manufacturing Requirementsunmatched
Marketingunmatched
Medical Equipmentunmatched
Product Lifecycleunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Risk Analysisunmatched
Risk Managementunmatched
Technical Leadershipunmatched
Technical/Engineering Designunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Traceabilityunmatched
Validation Planunmatched
Validation Testingunmatched
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