EU MDR Development Engineer II # 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