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22 days old

Product Development Engineer

Kelly Services
Memphis, TN 38111
**EU MDR Product Development Engineer**

**Location: Qualified candidates can work remotely**



**Duration: 12 month contract with the possibility of temp to hire**



**Pay: $52.00/hr plus benefits**





Kelly Services is seeking a skilled Product Development Engineer with heavy background in medical device and EU MDR requirements. Qualified candidates will have the opportunity to work on cutting edge technology and be able to work remotely from anywhere in the US.





RESPONSIBILITIES INCLUDE:




+ Assure product design history files meet the regulatory requirements of Medical Device Regulations (MDR 2017/745, internal quality system and other applicable regulations).

+ Work to update legacy product design history file to comply with EU MDR 2017/745 focusing on product design documents. This includes but is not limited to Product lists and product specifications.

+ Ability to analyze post market data and update design inputs as required based on current design and data.

+ Assess or perform, where necessary, design verification and validation to support acceptable design risk mitigation, which may include hazardous materials assessment, human factors analysis, and lifetime evaluations.

+ Work with Research and Development to produce evidence that products meet the requirements of applicable ISO, ASTM, IEC specifications.

+ Aid other groups to ensure that literature and labels reflect requirement of EU MDR

+ Work with packaging team to ensure packaging material risk is mitigated and captured with Product specifications as required by internal procedures and regulations.

+ Actively participate with cross functional teams to mitigate risk to acceptable level with adequate documentation. This includes but is not limited to Microbiology, Biocompatibility and Clinical.

+ Ability to identify products included in project based on planning and project charters/product families.

+ Apply knowledge of FDAs Guidance document for Design Control, ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.

+ Serve as primary development engineer on one or more EU MDR project teams. Ensure that required documentation/evidence is available in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, microbiology, biocompatibility, Clinical Affairs and production.

+ Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

+ Makes decisions and proposes solutions based on calculated risks identified through data analysis.

+ Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.

+ Coordinate activities with Management and Project Management Office (PMO) and report regularly on the progress of activities.

+ Participate in meeting departmental goals and objectives; on time project delivery per release project schedule

+ Work with counterparts in other divisions and countries.

+ Work to respond to questions posted by the Regulatory Affairs group and agencies with specified time.

+ Travel requirement: Occasional domestic travel may be required less than 10%

+ Other duties as assigned





EDUCATION REQUIRED

Bachelors degree in engineering or equivalent scientific discipline




YEARS OF EXPERIENCE

Preferred experience includes 4+ years at medical device company serving as a Product Development Engineer supporting design control teams with a BS degree. 2+ years experience creating product design specifications (i.e. drawings using Unigraphis/NX). Alternative considerations include 4+ years in product engineering experience in a GMP environment. 2+ years experience with a Masters degree.


QUALIFICATIONS





Required Qualifications




+ Clear and concise written and verbal communication Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves accountable

+ Self- starter, with the ability to work independently

+ Software programs - Microsoft Word, PowerPoint, Excel, Project.

+ Experience with managing documents within electronic PLM system

+ Corrective and Preventative action experience including root cause analysis

+ Experience with working with cross functional teams.



Standards and Regulations




+ EU MDR 2017/745




+ EU MDD 93/42/EEC

+ ISO 13485

+ 21 CFR Part 820

+ ISO 14971

+ 21 CFR Part 820

+ FDAs guidance document on Design Controls





Preferred Qualifications






+ Remoted working environment experience

+ Experience with Matrix PLM system

+ Experience with SAP

+ ASQ certification as a Certified Quality Biomedical engineer

+ Six-Sigma or equivalent green/blackbelt certification

+ Power-BI-Data Visualization





Standards and Regulations






+ IEC 62366

+ IEC 62304





Qualified candidates should email resume and references for consideration.



Kelly Services, Inc. is an Equal Opportunity Employer.




**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.

Categories

Posted: 2020-11-13 Expires: 2020-12-14

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Product Development Engineer

Kelly Services
Memphis, TN 38111

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