Kelly Services is currently seeking a contract R&D Sustaining Engineer in Brea, California! As a member of R&D Sustaining you will work closely with regulatory affairs, product development, quality, manufacturing, customer service, sales, marketing and procurement departments in support of global product registrations and product design, quality, customer service, and cost improvements.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Investigate and assess design history files (DHF), CE Tech Files, design specifications, test reports and manufacturing documentation to identify and resolve technical gaps and provide accurate and timely technical information for Regulatory submissions.
- Work closely with subject matter experts to development technical justification reports.
- Create performance verification protocols and write reports.
- Execute test protocols, summarize data, analyze and make conclusions.
- Prepare product drawings and illustrations for Regulatory submissions.
- Attend appropriate meetings – technical and core team, providing updates as required.
- Create and/or modify product design, product performance specifications, drawings, procedures, CAD models (SolidWorks).
- Create and execute Engineering Change Requests (ECR) in accordance with internal quality system procedures.
- Conduct product testing, field failure root cause investigations and develop, verify, validate and implement solutions in accordance with internal quality system procedures.
- Represent R&D Sustaining as a cross functional team member in support of product development, quality, manufacturing, customer service, sales, marketing, regulatory affairs and procurement department objectives.
- Ability to read, analyze, interpret, create, and meet; product specifications, technical procedures and worldwide governmental regulations.
- Ability to develop test protocols, execute testing, statistically analyze data, and develop conclusions.
- Ability to write technical reports and justifications.
- Excellent interpersonal skills along with the ability to work well within a team and able to collaborate with and influence others.
- Excellent oral and written communication skills.
EDUCATION and/or EXPERIENCE:
- Bachelor's in Mechanical Engineering or Materials Engineering required.
- 0-2 years engineering experience in medical device product development and/or manufacturing environment preferred.
- Experience with mechanical characterization methods such as tensile, compression or modulus testing preferred.
- FDA Quality System Regulation Part 820 and ISO 13485 experience preferred.
- Working knowledge of SolidWorks CAD software is required.
Apply today for immediate consideration!
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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