Senior Engineer/Principle Engineer

Yoh has a contract opportunity for a SENIOR ENGINEER/PRINCIPLE ENGINEER to join our client in Thousand Oaks, CA.

Client Overview:
Our client, a leader in biotechnology since 1980, was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Our client's therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.

Job Overview:
Lead teams in 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 lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design and development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Job Responsibilities:
- 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.
- Create and execute to project plans and schedules.
- 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.
- Provide deep technical assistance for junior engineers.

Job Qualifications:
- BS in Engineering and previous experience in a medical device industry.
- Ten (10) years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material and test specs generation, protocol and report writing, process and test development, prototyping, design verification, DOE/SPC process optimization and validation (IQ, OQ, PQ), FMEA.
- Experience in product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) and 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
- 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.
- IMPORTANT NOTE: Qualified candidates with a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.

Yoh, a Day J2W: CLINICAL

MONJOB

J2WNWPHA

Ref:

SFSF: LS