1+ months

R&D Engineer

Kelly Services
Fairburn, GA 30213
**_R&D Engineer_**

**_Atlanta, GA_**

**_Direct Hire_**

Kelly Engineering is looking to hire a R&D Engineer to join one of the fastest growing business segments, a Medical Device Manufacturer who is focused on Design and Development of medical devices for various applications.

**Job Description:**

This role will rely heavily on world-class analytical capabilities and business acumen coupled with an ability to quickly develop and help implement identified improvement opportunities. We expect this role to have a continuous improvement mindset and to help drive this culture throughout the organization. This role will be responsible for the 3D mechanical design and project management of medical device that we are developing

**Key Attributes**

The ideal candidate will be a creative problem solver with an intellectual curiosity coupled with a strong desire for on-going learning and development. They will have a bachelors in engineering (Mechanical, Biomedical or Chemical Engineering), with 4-5 years experience in:

+ Medical device design and development.

+ Design and scale-up experience in plastics and metal components

+ Design for manufacturing

+ Risk management

+ 510(k) filings

+ QSR and ISO regulatory environments

+ Statistical Data Analysis

+ Project management

They will also be capable of quickly establishing credibility, influencing decision makers, and persuading professionals at all levels. A key attribute will be an organizational development expert who transforms strategy into operational goals and objectives, achieves desired outcomes, and effectively leads people through change. Candidates should be able to highlight their IMPACT as a leader throughout their organization(s) and able to thrive in a fast-paced and result- oriented environment.

**The R&D Engineer will:**

+ Assist in the development and launch of our new products in the Life Sciences market.

+ Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.

+ Leverage his/her technical expertise related to medical devices to assist with creating new device designs, maintain technical files, conduct verification and validation studies, conduct risk analysis, and assist with design transfer to manufacturing.

+ Asist in project management and making sure project will be executed to meet business goals.

**Essential Duties and Responsibilities. Other duties may be assigned.:**

+ Develops project schedules for the product development team and ensures timely execution.

+ Provide reports on project status. Identifies, tracks, and resolves all project risks and issues.

+ Provide day-to-day guidance and oversight of team activities; actively works to recognize performance.

+ Provide feedback to management on development and delivery; report/escalate to management as needed

+ Identify all tasks required to complete project assignments per Design Control procedures.

+ Prepare SolidWorks models and final production drawings.

+ Prepares verification and validation protocols and test reports

+ Participate in non-conforming product investigations and CAPAs.

+ Maintain compliance with QMS system compatible with 21CFR-820 and ISO-13485.

+ Prepare Design History Records (DHR) for manufacturing R&D products

+ Create work instructions and standard operating procedures (SOPs) as required.

+ Analysis data for reports using statistical tool such as Minitab.

+ Maintains company documentation per standard operating procedures

+ Performs experiments in accordance with the requirements of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or Quality System Regulations (QSR)

+ Mitigates technical and operational risk and ensure flawless execution of projects.

+ Travel to manufacturing locations to facilitate resolution of manufacturing problems.

+ Assist in identifying and qualifying new suppliers.

+ Assist with the preparation of regulatory submissions.

**Education and/or Experience:**

+ In engineering (Mechanical, Biomedical or Chemical Engineering), with Minimum of 5 years medical device development experience in FDA regulated environment required,

+ Ability to create complex mechanism designs and 3-D CAD principles as well as detailed mechanical specifications and drawings (prefer solidworks).

+ 510(k) experience is an additional benefit

+ Ability to understand and apply GD & T and tolerance stack up analysis.

+ Experience in venting and pressurizing system design and analysis.

+ Background in Injection Molding, Automated Assembly, 3-D manufacturing and PPAP experience as they relate to medical device a plus.

+ DFMEA and ISO 14971 Risk Management experience.

+ Understanding of design controls, DHF, and Gate Process life cycle

+ Ability to perform design for manufacturing (DFM) analysis for different technologies (machining, molding, stamping etc.)

+ Ability to present and participate in design reviews.

+ Manage project tasks, deliverables, dependencies, and resource requirements

+ Experience with extrusions, rubber compression molding, plastic injection molding.

+ Familiarity with quality processes: IQC, OQC, CAPAs, RCA, 8D and or A3 methodology.

+ Minitab and or experience with process capability analysis.

+ GR&R experience.

+ Fixture design and manufacturing.

+ Ability to review marketing claims and develop test methods and design of experiments to validate performance.

+ Minimum computer skills: SolidWorks, project management software, and Microsoft Office suite.

\#P1 #TJP2022_SPEC

**Why Kelly** **** **Engineering?**

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 (plus, did we mention we provide a ton of benefits ?). 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-08-29 Expires: 2022-10-29

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R&D Engineer

Kelly Services
Fairburn, GA 30213

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