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9 days old

Development Engineer, Memphis, TN

Kelly Services
Memphis, TN 38111
**Development Engineer, Memphis, TN**


**12 month contract via Kelly Engineering**


**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).


o 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.


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


o 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.


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


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


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


o 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


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


**Why Kelly?**


**Kelly Services is committed to employee inclusion through our dedication to foster an innovative workforce by recognizing, celebrating, and embracing the diversity that all Kelly employees bring to our organization and our customers.**


As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.


**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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.


**\#KellyGTS**


**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.

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Posted: 2021-04-30 Expires: 2021-05-31

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Development Engineer, Memphis, TN

Kelly Services
Memphis, TN 38111

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