IG
Research And Development Engineer
Accepting applicationsInsight Global · Arden Hills, MN
Contract Mid_senior
Posted
3d ago
Category
Verification
Experience
Mid_senior
Country
United States
Job Overview:
Insight Global is seeking a Mechanical R&D Engineer to support an integration project for one of our clients. This role focuses on bringing the acquired company's Design History File (DHF) into compliance with our clients' standards. Key responsibilities include design verification, test method development and validation, engineering documentation, requirements tracing, technical problem-solving, and cross-functional collaboration. (This person can sit in Arden Hills, MN or Marlborough, MA, or Valencia, CA).
Must-Have Qualifications
Bachelor's degree or higher in: Mechanical Engineering or Biomedical Engineering
Electromechanical Engineering
Related engineering discipline
4+ years of medical device engineering experience with a Bachelor's degree OR 2+ years with a Master's degree
Experience with: Design verification and verification testing, Test method development and validation, Engineering documentation and Design History Files (DHF), Requirements tracing and design controls, Technical problem-solving and root cause analysis
Strong mechanical and/or systems engineering background
Ability to analyze technical data and make recommendations
Strong written and verbal communication skills
Demonstrated collaboration, critical thinking, and decision-making abilities
Highly self-motivated with strong accountability and bias for action
Ability to travel up to 10%;
Preferred Qualifications:
Familiarity with: IEC 14708 and IEC 45502 Active Implantable Medical Device standards and IEC 60601 Medical Electrical Equipment standards
Experience with:
Design FMEA
Essential Design Outputs (EDOs)
System, subsystem, and component requirements tracing
Statistical analysis tools and methodologies (Gauge R&R, Process Capability Studies, Minitab)
Cognition Cockpit or similar requirements management platforms
Single-use device testing
Active implantable device testing
Test method validation
Strong relationship-building skills across internal teams and external stakeholders
Key Responsibilities:
Support design outputs and design verification activities
Develop and validate test methods
Execute verification testing and documentation
Create DHF deliverables, protocols, reports, and technical rationales
Support requirements tracing and Design FMEA activities
Assess and leverage acquired company documentation where appropriate
Communicate project risks, progress, and recommendations to leadership
Resolve technical issues and recommend engineering solutions
Deliver high-quality documentation in compliance with Boston Scientific design control requirements
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Insight Global is seeking a Mechanical R&D Engineer to support an integration project for one of our clients. This role focuses on bringing the acquired company's Design History File (DHF) into compliance with our clients' standards. Key responsibilities include design verification, test method development and validation, engineering documentation, requirements tracing, technical problem-solving, and cross-functional collaboration. (This person can sit in Arden Hills, MN or Marlborough, MA, or Valencia, CA).
Must-Have Qualifications
Bachelor's degree or higher in: Mechanical Engineering or Biomedical Engineering
Electromechanical Engineering
Related engineering discipline
4+ years of medical device engineering experience with a Bachelor's degree OR 2+ years with a Master's degree
Experience with: Design verification and verification testing, Test method development and validation, Engineering documentation and Design History Files (DHF), Requirements tracing and design controls, Technical problem-solving and root cause analysis
Strong mechanical and/or systems engineering background
Ability to analyze technical data and make recommendations
Strong written and verbal communication skills
Demonstrated collaboration, critical thinking, and decision-making abilities
Highly self-motivated with strong accountability and bias for action
Ability to travel up to 10%;
Preferred Qualifications:
Familiarity with: IEC 14708 and IEC 45502 Active Implantable Medical Device standards and IEC 60601 Medical Electrical Equipment standards
Experience with:
Design FMEA
Essential Design Outputs (EDOs)
System, subsystem, and component requirements tracing
Statistical analysis tools and methodologies (Gauge R&R, Process Capability Studies, Minitab)
Cognition Cockpit or similar requirements management platforms
Single-use device testing
Active implantable device testing
Test method validation
Strong relationship-building skills across internal teams and external stakeholders
Key Responsibilities:
Support design outputs and design verification activities
Develop and validate test methods
Execute verification testing and documentation
Create DHF deliverables, protocols, reports, and technical rationales
Support requirements tracing and Design FMEA activities
Assess and leverage acquired company documentation where appropriate
Communicate project risks, progress, and recommendations to leadership
Resolve technical issues and recommend engineering solutions
Deliver high-quality documentation in compliance with Boston Scientific design control requirements
Show more Show less