22 days old

R&D Engineer

Kelly Services
Atlanta, GA 30326
**R&D Engineer- Atlanta, GA- Direct Hire**


We are an established global leader in one-of-a-kind solutions for the healthcare, consumer, and industrial markets. Our mission is to make the world Safer, Healthier, and More Productive. We have a unique non-corporate culture that values a Bias for Action, Trust and an Entrepreneurial mindset. We value our team members and place a strong focus on their development through a robust talent management program. We run towards problems and opportunities to drive business results. If this sounds like a company that shares your values, then we may have an opportunity for you.

We are seeking a **Research and Design Engineer** to join one of our fastest growing business segments, a Medical Device Manufacturer who is focused on developing medical devices for various applications.

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.

**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:**

**The medical device design and development or automotive industry**

**Design and scale-up experience in plastics components**

**510(k) filings**

**QSR and ISO regulatory environments**

**Statistical Data Analysis**

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 RDE will:**

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

+ Leverage your 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.

**Key Deliverables**

+ Design Verification Test Plan and Report, including statistical sample size justification.

+ Develop and manage BOMs, part numbering systems, drawing and model change documentation

+ Document control using PLM system

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

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

+ Assist in compliance with documentation, traceability, training and calibration requirements

+ Assist with the preparation of regulatory submissions

+ Participate in non-conforming product investigations and CAPAs as needed

+ Develop and maintain Device Master Records (DMRs), Test Protocols, and Reports

+ Assist in identifying and qualifying new suppliers.

+ Travel to manufacturing locations to facilitate resolution of manufacturing problems

**Core Competencies**

+ Ability to find and partner with external vendors to extend testing capabilities for design and development verification activities.

+ Expertise in Statistical Analysis of data

+ Proactive, with a demonstrated ability to lead, and relishes working with limited direction and oversight.

+ Must have strong interpersonal skills including interacting with hourly manufacturing associates, customers, and suppliers.

+ Excellent relationship building skills and the ability to work effectively in a team environment working across function and business units.

+ Confident and self-aware with excellent interpersonal and communication skills, both written and verbal.

+ Strong analytical abilities and critical thinking skills; strengths in problem solving and root cause analysis.

+ Proficient in Microsoft Office products, including Word, Excel, PowerPoint and Outlook

**Education and Experience**

+ Bachelors Degree in Engineering (Mechanical, Biomedical or Chemical Engineering), equivalent training and/or experience, and direct experience with medical device industry and related QSR and ISO regulatory environments.

+ 5+ years experience in manufacturing required.

+ 510(k) experience high desirable and preferred

+ Experience in GD&T in design and development specifications

+ 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

+ Advanced Solidworks Modeling - surface modeling, working with many configurations

+ 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

+ DFM and DFA experience


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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

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, were here every step of the way to find your dream engineering job.

**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 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.
Posted: 2021-11-05 Expires: 2021-12-13

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R&D Engineer

Kelly Services
Atlanta, GA 30326

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