Mechanical Engineer Job

A MECHANICAL ENGINEER is needed for a LONG TERM CONTRACT opportunity with Yoh's client located in Thousand Oaks, CA.

WHAT YOU'LL BE DOING:

- Support the development of drug delivery devices. 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.
- The qualified candidate will support technical teams to ensure successful device development of these mechanical medical devices. The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
- The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
- Create and execute to technical protocols and prepare technical reports to support development and commercialization of the combination products.
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.

WHAT YOU NEED TO BRING TO THE TABLE

- BS in Engineering and previous experience in a medical device industry
- Three (3) years current experience with engineering processes and procedures.
- Supported projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development
- Familiar with the following standards:
- Quality System Regulation - 21CFR820
- Risk Management - ISO 14971
- Needle based injection system - ISO -11608, FDA guidance on pen, injectors
- EU Medical Device requirements - Council Directive 93/42/EEC
- 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.

GET HIRED, APPLY NOW!

RECRUITER: James Dangler

Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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

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