Engineer, Design Assurance#26-22874 $96.96-$103.22 per hour Pleasanton, CA Onsite Job Description Subject Matter Expert (SME) is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support.

Position Summary:

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element. Interprets regulations and requirements to lead, coach, and mentor teams on Risk Management. SME for domestic/international sites and affiliates regarding Risk Management Quality System element. Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation. Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments. Perform Health Hazard and Regulatory Risk Evaluations Bachelors Degree (± 16 years) Engineering or Technical Field Experience Experience Details Both overall and any industry-specific experience needed: 5 years i. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance. ii. Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred. Experience with risk management (ISO 14971) required. Knowledge of various tools and techniques for Risk Management is desirable. Knowledge of IEC60601-1 or electrical safety is desirable. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

1.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. 2. Manage new risk management file 3. Work with Engineering, Marketing, Manufacturing and Regulatory to establish risk management files. 4. Understands test plan protocols, test procedures, and test reports used for risk controls. 5. Understand design verification and design validation plans and links to the risk management files. 6. Understands implication of risk management in Verification and Validation sampling plans. 7. Able to lead technical discussions of products and associated risk management documentation.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."