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R&D Engineer III
3 months ago
Job Summary:
At Talent Software Services we are looking for a skilled Business Analyst for a contract position in Valencia, CA (Hybrid). This opportunity spans over a year with a high potential for a long-term extension.
Position Summary:
- Providing engineering support for integration activities related to an acquisition.
- Ensuring oversight of design, quality, manufacturing, and project-related tasks.
- Collaborating with internal teams and external suppliers to identify and execute projects.
- Applying project management and problem-solving skills to handle multiple tasks simultaneously. Developing products, materials, processes, or equipment for projects with moderate complexity.
Working with minimal supervision, compiling, analyzing, and reporting operational, test, and research data to set performance standards for newly designed or modified products, processes, and materials.
- 15% domestic travel may be required
Primary Responsibilities/Accountabilities:
- Remediation of all Design Control aspects of an acquisition through:o Development of new requirements, sourcing new requirements, creation and validation of new test methods, preparation of new risk documentation, and conducting all relevant testing.
- Supporting manufacturing transitions from one vendor to another.
- Assisting in project work for EUMDR approval.
- Ensuring product safety, quality, and compliance across all products.
- Proficient in change management processes (DCA, SCIA, SCAR, and PLCP).
- Supporting all R&D project planning and tasks.
- Adhering to regulations governing the quality system.
- Supporting additional business-required activities.
- Incorporating quality into all work by complying with quality standards.
Qualifications:
- 8 Years with BS,
- 6 Years with MS, 0
- 3 Years with PhD
- At least 2 years of experience as a project leader/manager.
- Over 2 years working with FDA Quality System Regulations and ISO 13485.
- Experience in evaluating quality and compliance impacts on products during design and process changes.
- Proficiency in design verification and validation activities.
- Familiarity with Test Method development.
- Experience in troubleshooting and root cause analysis.
- Self-motivated with the ability to work independently.
- Proficiency in MiniTab and SolidWorks.
- Strong written (assessments, protocols, reports, and email) and verbal communication skills.
Preferred:
- Experience leading 4+ projects driving product design or process changes is favored.
- 3+ years of Electro/Mechanical experience.
- Involvement in at least 4 new product development projects, related to product transfer and scale-up activities is beneficial.
Familiarity with manufacturing processes such as silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing, and packaging.
Experience with SAP and Windchill is advantageous.- Human Factors / Usability experience is beneficial.
If your background matches this role, we would love to receive your application.
Providing consulting opportunities to skilled individuals since 1987, we offer various options including contract, contract to hire, and permanent placements.
