We have an outstanding Contract position for aSenior R&D Engineerto join a leading Company located in theValencia, CAsurrounding area.
Ensuring all Design Controls aspects of an acquisition are remediated through:
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, SCI A, SCAR, and PLCP).
Supports any applicable R&D projects planning and activities.
Understands and complies with all the regulations governing the quality system.
Supports additional activities required by the business.
Basic Hiring Criteria:
5 - 8 years of exprience with Bachelor's degree.
2+ years working with design controls.
2+ year 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 validations activities.
Experience with Test Method development.
Experience in troubleshooting and root cause analysis.
Self-motivated individual that can work independently.
Working knowledge of MiniTab and SolidWorks.
Good writing (assessments, protocols, reports, and email) and verbal communication skills.
Desired Qualifications:
Has led 4+ projects to drive product design changes or process changes preferred.
3+ years 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.
Benefits offered to vary by the contract. Depending on your temporary assignment, benefits may include direct deposit, free career counseling services, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonus, affordable medical coverage plan, and DailyPay (in some locations). For a full description of benefits available to you, be sure to talk with your recruiter.
VEVRAA Federal Contractor / Request Priority Protected Veteran Referrals / Equal Opportunity Employer / Veterans / Disabled
The Company will consider qualified applicants with arrest and conviction records.
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