EU MDR Development Engineer II # JN -072021-66580

Andover, Massachusetts
Industry: Database Administrator / Engineers
Job Number: JN -072021-66580

Description:

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 gab analysis and evaluation of standards and compliance
  • 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 an project charters/product families.
  • 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

 

 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

 

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 3D CAD software UG or comparable
  • 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 MDD 93/42/EEC
  • ISO 13485

 

Standards and Regulations

  • IEC 62366
  • IEC 62304
  • EU MDR 2017/745
  • 21 CFR Part 820
  • ISO 14971
  • 21 CFR Part 820
  • FDA’s guidance document on Design Controls


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