Sr Product Development Engineer Life Science at YOH Services LLC in Menlo Park, California

Job Description:

YOH is seeking a Sr. Product Development Engineer in Menlo Park, CA, for a fulltime salary position. This person should have previous working experience in the field of Engineering. A candidate should be able to write protocols, collaborate with a team, and create prototypes of new products. This is a good opportunity to make impact quickly on current products and have products to the market. This candidate needs a minimum of a Bachelors in Engineering and 5 years of relevant work experience.

Pay Rate: Based Upon Experience

Hours: Monday-Friday 9am-5pm

Industry: R&D

Location: Menlo Park, CA

Type: Direct Hire

Primary Responsibilities:

- Define requirements for next generation product offerings. Establish clear problem statements, bring-to-light design opportunities and enable effective solutions.

-Work with the team to align on product development objectives and priorities to ensure product enhancements are successfully received in the market.

- Create and iterate prototypes, generate specifications, define test methods, produce and release DHF documentation, and ensure manufacturable, reliable, well documented designs that readily transfer to commercial production.

- Develop design output solutions that successfully meet user needs and demonstrably satisfy engineering requirements with bench, cadaver, and/or user testing. Develop test method and protocols, perform V&V activities, and generate detailed technical reports that meet company standards.

- Evaluate supplier capabilities in a deliberate, structured, and detailed fashion to guarantee alignment between capability and product requirements.

- Generate detailed component & assembly drawings to define design requirements, in accordance with GD&T where applicable.

- Provide an example to others by producing quality results, accounting for product and business risks, conducting effective testing, generating comprehensive reports, and navigating projects efficiently with a fast-paced cadence.

- Develop relationships with customer representatives to harness a strong understanding of product performance expectations and the competitive landscape. Formulate an understanding of diagnostic and treatment technologies related to the Company's objectives.

- Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements.



Qualifications:



-BS or MS in Engineering or equivalent with experience in a product development environment.

- Minimum 5 years of related experience in the medical device industry.

- Experience developing product within multiple phases of design control.

- Successfully contributed to transferring a product into manufacturing. Generated and/or managed manufacturing documentation for a commercial medical device.

- Versed in V&V, GMP, and state-of-the-art production practices.

- Capable with SolidWorks modeling, engineering drawing generation, GDT, DFM, design for injection molding and other volume processes, tolerance analysis and tooling design.

- Proven track record using a variety of design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate the value of new concepts.

- Strong familiarity with medical device risk management and design control procedures and understanding of regulatory requirements and guidance.

- Familiar with Quality compliance requirements as well as Regulatory standards and guidance for US and International marketed medical device products.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

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