New Product Development Quality Engineer
A biotech manufacturing company in Sunnyvale, CA is seeking a New Product Development Quality Engineer to work on technical projects in a Medical Device New Product Introduction setting. The successful candidate will facilitate the completion of New Product Development projects by organizing and controlling Quality elements and timelines. The NPD Quality Engineer functions as the Quality Engineering Representative to cross-functional core teams with responsibility for the project from a Quality and Compliance perspective.
- Applies technical experience, skill and performance to achieve strategic goals through new product delivery from a Quality perspective.
- Works cross-functionally and consults frequently with Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing, in addition to other functional groups.
- Routinely communicates project goals, status, requirements, and deliverables to Quality Program Manager and/or supervisor.
- Document the phase gate process for new product development from a Quality perspective and ensure compliance to Cepheid and Danaher policies and procedures.
- Function as the Quality Engineering representative and continuously communicate with Core Team members and their extended teams to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
- Create the Quality Plan, Validation Master Plans and Reports
- Collaborate with Core Team on Quality-related project activities including risk assessments, and facilitates resolution for Quality-related issues escalated to the Core Team
- Communication focal point for the project to Quality Management, including Quality Program Manager and/or supervisor
- Establish project milestones and monitor adherence to master plan
- Work effectively with all team members and stakeholders
- Effectively communicate and maintain visual tools for project tracking and management
- Effectively employs company tools and concepts to maximize efficiency and quality
Bachelor’s Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of five (5) years related experience OR Master’s degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of three (3) years related experience.
A minimum of three (3) years of FDA regulated environment experience
Proven track record with design control in medical device system and/or reagent product development.
Experience in the application of production and process controls including process validation.
Demonstrated leadership skills and the ability to influence others.
Experience with and/or practical knowledge about quality system audits.
Demonstrated superior communication skills, both oral and written.
Fast learner, and able to quickly become adept at using the Danaher Business System tool set.
Readily accepts responsibility and accountability for project success and key decisions
Ability to lift 25 pound instruments.
Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485
A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, etc.
Experience in product mechanical evaluation & testing and GD&T
Experience in in-vitro diagnostic (IVD) industry and/or reagent or manufacturing calibration dye chemistry
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.