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EU MDR Development Engineer II


Location: Andover, Massachusetts
Job Category:


EU MDR – Development Engineer
12+ month contract 
Andover, MA (remote) 

Job overview:
• Serve as 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.
• Assure product design history files meet the regulatory requirements of Medical Device
Regulations (MDR 2017/745, internal quality system and other applicable regulations).
• Work independently 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.
• 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.
• Evaluate materials using CAD models, chemical composition charts, material data sheets,
European chemical Agency and other internal and external references to determine and
document hazardous and non-hazardous state of materials.
• Identify products included in project based on planning and project charters/product families.
• 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.
• Serve as SME during internal and external audits.
• Assist in the development of the quality system but writing documents, releasing documents and
providing training.
• Other duties as assigned.
Location: Memphis, TN or Remote
REQUIREMENTS:
Education: Bachelor’s Degree in Engineering
Experience:
• 2+ years at medical device company serving as a Product Development Engineer supporting
design control teams
• 2+ years' experience creating product design specifications (i.e. drawings using Unigraphics/NX).
Required Qualifications:
• Working knowledge of the anatomy
• Working knowledge of orthopedic implants and instruments (i.e. hips, knees, plates, screws,
nails, etc.)
• Ability to apply knowledge of FDA’s Guidance document for Design Control, ISO 14971 Risk
Management; and other applicable standards to sustaining engineering projects
• 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
• Ability to work independently to complete assigned project deliverables on time
Experience working in a remote environment
Standards and Regulations:
• • EU MDR 2017/745
• • EU MDD 93/42/EEC
• • ISO 13485
Preferred Qualifications:
• Experience with Matrix PLM system
Experience with SAP
• Power-BI-Data Visualization
Standards and Regulations:
• IEC 62366
• IEC 62304
• ISO13485

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