Senior Engineer Job

SENIOR ENGINEER needed for a CONTRACT opportunity with Yoh's client located in South Thousand Oaks, CA.

WHAT YOU'LL BE DOING:

- Lead teams in conducting and documenting risk assessment of drug delivery devices.
- Participate as a member of cross-functional development teams for drug delivery systems.
- Author and gain review and approval of risk management documents.
- Scope includes a wide range of devices such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- Support drug delivery projects with primary responsibility for risk management activities:
- Prepare for and facilitate risk assessments throughout the product development life cycle.
- Provide risk mitigation recommendations from risk assessments to the system development team.
- Maintain coordination of risk management activities with product requirements and verification/validation activities.
- Provide estimates of risk management efforts to project management and participate in project scheduling.
- Maintain knowledge of and compliance with applicable standards and operating procedures.
- Provide expertise in systems engineering, with emphasis on risk management, in aiding development teams to understand the interactions of risk management with the overall product development process.

WHAT YOU NEED TO BRING TO THE TABLE:

- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- Background in engineering and commercialization of electro-mechanical medical devices.
- Product design/development experience
- Experience in drug/device combination product design and development
- Familiar with the following standards:
- Quality System Regulation - 21CFR820
- Risk Management - ISO 14971
- EU Medical Device requirements - Council Directive 93/42/EEC
- Medical Electrical Equipment - EN 60601
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Rob West

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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