EU MDR Development Engineer II # JN -072021-66580
Posted on: July 7, 2021
Industry: Database Administrator / Engineers
Job Number: JN -072021-66580
- 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
- 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
- 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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