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30 days old

Principal Engineer (Medical Device)

Kelly Services
Deerfield, IL 60015
**Principal Engineer**


**Location: Deerfield IL**


**This is a 12 + month Contract to hire opportunity!**


**Hours per week: 40+**


**Summary:**


Engineer will be responsible for developing new products used in surgical procedures, through partnerships with R&D and other cross functional team members. Strong understanding of Quality compliance i.e. building quality into products through design control and compliance with procedures. Engineer should be able to navigate with sustaining the products in the field in compliance with the quality system and technical expertise and have had hands on experience with product development and risk management activities.


**Responsibilities:**


+ Ensure compliance to procedures, especially Design Control and Risk Management with respect to development of new products. Active participant in the Core Team, applying engineering knowledge to move projects forward successfully.

+ Ensure compliance to Change Control procedures to make changes to currently marketed product.

+ Act independently as QA R&D product SME with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on science & technical knowledge.

+ Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.

+ Manage routine small projects without assistance. Coordinates with cross functional team to set realistic timelines and set team for success.

+ Recommend design improvements via customer feedback investigation and analysis.


**Qualifications:**


+ Knowledge of the basic principles in various engineering disciplines. Must have experience in product development demonstrating proficiency in Design control elements, problem solving, total quality management, statistical methods, DHF development, Risk file creation, problem analysis and resolution, materials science, design of experiments etc.

+ Must have initial training in concepts of


+ Six Sigma

+ quality techniques.


+ Completely proficient in relevant product development processes in compliance with FDA design control 21CFR820.3 and ISO13485

+ Good understanding of EUMDR desired; extensive cross-functional team experience, including technical and non-technical work.


**Education/Experience:**


+ BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)

+ At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.

+ Extensive medical device design controls experience.

+ Software: Word, Excel, Visio, PowerPoint, Outlook

+ Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency

+ Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence.


**Why Kelly?**


As a Kelly employee, youll have access to world-class perks, including:


+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts


*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.


**Apply Today!**


*Important information: This position is recruited by a remote, national, Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**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/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.
Posted: 2021-01-29 Expires: 2021-03-04

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Principal Engineer (Medical Device)

Kelly Services
Deerfield, IL 60015

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