EU MDR Development Engineer
• 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 requlationsregulations.
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 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.
• 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
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.
• 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
• 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
- (American Society For Quality) Asq Certified
- Biomedical Engineering
- Change Management
- Clinical Works