Design AssuranceEngineer

Spectraforce Technologies; Pleasanton (CA); On-site; USD 90,000 - 120,000; Part time

Job summary

Spectraforce Technologies in Pleasanton, CA is seeking a Design Assurance Engineer for a 6-month assignment to develop and maintain quality systems and risk management activities in support of new product development, manufacturing and post-market support.

You will lead ISO 14971 based risk analyses, manage risk management files, and collaborate with Engineering, Regulatory and Quality teams to ensure GMP/ISO compliant processes. Strong documentation and communication skills required.

Qualifications

• Experience with risk management requirements and quality systems in medical device or related industries.
• Experience in risk analysis (Hazard Analysis, FMEA) and risk control documentation.
• Familiarity with GMP/ISO quality system practices and IEC60601-1 is desirable.
• Strong ability to communicate across functions and document results clearly.
• Experience in a matrixed, multi-site environment is a plus.

Responsibilities

• Lead design assurance activities in support of risk management files (Hazard Analysis, FMEA, Risk Management Planning, Risk Management Report, Benefit Risk Analysis) per ISO 14971 guidelines.
• Manage new risk management files and ensure timely updates.
• Collaborate with Engineering, Marketing, Manufacturing and Regulatory to establish risk management documentation.
• Understand design verification and design validation plans and link them to risk management files.
• Support risk management considerations in Verification and Validation sampling plans and product discussions.

Skills

Risk Management

ISO 14971

GMP/ISO Knowledge

Quality System

Cross-functional Collaboration

Education

Bachelor's Degree in Engineering or Technical Field

Job description

Position Title: Design Assurance Engineer

Work Location: Pleasanton, CA, USA, 94588

Assignment Duration: 6 months (possible extension)

Work Schedule: 6 AM to 2:30 PM

Position Summary:

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. A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.

Key Responsibilities:

• 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.
• Understands 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.
• Understands implication of risk management in Verification and Validation sampling plans.
• Able to lead technical discussions of products and associated risk management documentation.

Qualification & Experience:

• 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.