Product Engineer/Medical Device - Remote

  • location: Cordova, TN
  • type: Contract
  • salary: $40 - $50 per hour
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job description

Product Engineer/Medical Device - Remote

job summary:
Great and growing client is looking for a Quality Engineer to work remotely for a 12 month contract. This candidate will assure product design history files meet the regulatory requirements of Medical Device Regulations (MDR 2017/745, internal quality system and other applicable regulations).

 
location: Cordova, Tennessee
job type: Contract
salary: $40 - 50 per hour
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:
  • 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 requlations.
  • 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 an project charters/product families.
  • Apply knowledge of FDA's 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.
 
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
  • FDA's 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
Experience with Standards and Regulations

  • IEC 62366
  • IEC 62304
EDUCATION REQUIRED

  • Bachelor's 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 Master's degree
 
skills:

  • Quality Engineer, Medical Device Regulations, Design Control, Product Development, Unigraphics/NX, GMP
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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