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R&D Engineer III
2 weeks ago
R&D Engineer III
Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.
Job Summary: Talent Software Services is in search of a Business Analyst for a contract position in Valencia, CA(Hybrid). The opportunity will be one year with a strong chance for a long-term extension.
Position Summary:Provides engineering support for integration activities for an acquisition..
Provides oversight of the design, quality, manufacturing, and project-related activities.
Coordinates with internal functions and external suppliers to identify and execute projects.
Applies project management and problem-solving skills to manage multiple activities concurrently. Develops products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, compiles analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
5 - 15% domestic travel possible
Primary Responsibilities/Accountabilities:Ensuring all Design Control aspects of an acquisition are remediated through:o Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing
Supporting manufacturing moves from one vendor to another.
Supporting project work for EUMDR approval.
Maintains product safety, quality, and compliance of all products.
Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
Supports any applicable R&D project planning and activities.
Understands and complies with all the regulations governing the quality system.
Supports additional activities required by the business.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications:5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD
2+ years working with design controls.
2+ years of project leader/manager experience.
2+ years working within FDA Quality System Regulations and ISO 13485.
Experience with assessing quality and compliance impact on products for design and process changes.
Experience with design verification and validation activities.
Experience with Test Method development.
Experience in troubleshooting and root cause analysis.
Self-motivated individual who can work independently.
Working knowledge of MiniTab and SolidWorks.
Good writing (assessments, protocols, reports, and email) and verbal communication skills.
Preferred:Has led 4+ projects to drive product design changes or process changes preferred.
3+ years of Electro/Mechanical experience.
Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.
Knowledge of manufacturing processes including; silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing, and packaging.
SAP and Windchill experience is a plus.
Human Factors / Usability experience is a plus.
If this job is a match for your background, we would be honored to receive your application
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk
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