Industry: Manufacturing – Medical Devices
Work Location: Memphis, TN
Job Title: New Product (R & D) Engineer
Duration: 6-12 Months (Temporary/Contract)
New Product R & D Engineer – Memphis, TN
Kelly Services is currently seeking a New Product R & D Engineer for one of our top clients in Memphis, TN.
This position has the responsibility of working in the R&D and Quality Engineering MDR Workstream to plan and execute R&D/Quality activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards, comply with regulatory and compliance standards. Job responsibilities include addressing well defined problems of limited scope and following standard practices and procedures.
This workstream is responsible for ensuring all product related documentation submitted as part of a technical file is remediated to standards required by the MDR legislation. In addition, new processes must be established for NPD projects to ensure future MDR compliance – including those within the current project pipeline and future project initiation.
Update of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings
Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements
Ensure that all product testing data (e.g. MRI, biocompatibility) is remediated or developed to MDR standards
Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation
Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation
Prepare Design History files and other required supporting documentation for a notified body pilot
Provides R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records
Travel – Domestic International – Up to 10%
Bachelor's degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field.
CAD experience beneficial
Intern experience in an engineering field a plus
Ability to work effectively in a cross-functional team environment
High learning agility
Strong written and verbal communication and technical writing skills
Analytical approach to problem solving
Bachelor's degree in Manufacturing or Industrial Engineering
Must be in excellent academic standing, with a 3.0 or above preferred
Previous applicable internship, co-op, part-time or apprenticeship experience is preferred. Some knowledge of medical devices/manufacturing standards, methods and processes are a plus
Demonstrated leadership experience preferred; a proven and effective project leader preferred.
Strong communication skills including technical writing, listening and speaking; ability to influence others
High learning agility with the ability to analyze and synthesize data and then present it to senior leaders
Must be able to communicate effectively with cross-functional teams and drive project completion
Independent thinking and the ability to work within a team is required
Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving
Requires the ability to manage tight deadlines, multiple tasks, assignment changes, periodic heavy workload, rapidly changing technology, and dynamic business growth; time management and organization skills are a must
Travel Requirements: <0-10%
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] 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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