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Senior R&D Engineer

Intellectt INC

Minnesota City, MN

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JOB DETAILS
SKILLS
Acquisition Integration, Bill of Materials (BOM), Biomedical Engineering, Catheterization, Change Control, Communication Skills, Cross-Functional, Document Management, Documentation, Feasibility Analysis, File Maintenance, Integration Testing, Leadership, Manufacturing Requirements, Material Science, Mechanical Engineering, Medical Equipment, Problem Solving Skills, Product Support, Prototyping, Quality Assurance Methodology, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Requirements Management, Research & Development (R&D), Risk Management, Root Cause Analysis, System Integration (SI), Technical Leadership, Test Plan/Schedule, Traceability, Validation Testing, Windchill PLM Software
LOCATION
Minnesota City, MN
POSTED
7 days ago

Senior R&D Engineer Medical Device Integration (Contract)

We are hiring an experienced Senior R&D Engineer to lead design, development, and integration activities within a high-impact medical device program operating under a robust quality system. This is a long-term contract opportunity through the end of 2026, with strong potential for extension.

Key Responsibilities

  • Lead technical integration workstreams, including interface definition, requirements alignment, planning, and execution
  • Drive design control activities in compliance with regulatory and quality standards
  • Own and maintain Design History File (DHF) documentation, including user needs, design inputs/outputs, traceability matrices, and risk management files
  • Develop and execute Verification & Validation (V&V) strategies and protocols
  • Conduct feasibility studies, prototype development, testing, and integration readiness activities
  • Perform root cause analysis and resolve complex technical and system integration issues
  • Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Supplier Engineering teams
  • Provide technical leadership and effectively communicate with cross-functional stakeholders

Required Qualifications

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related field
  • 6+ years of experience in the medical device industry (4+ years with an advanced degree)
  • Strong experience working within a design controls environment
  • Hands-on experience with catheter-based and/or single-use medical devices
  • Solid understanding of design controls, DHF documentation, risk management, V&V, traceability, and change control
  • Proven ability to lead technical initiatives independently and collaborate across functions
  • Strong problem-solving, communication, and stakeholder management skills

Preferred Qualifications

  • Experience with balloon catheter systems or similar technologies
  • Familiarity with Windchill or other PLM/quality management systems
  • Experience supporting DMR deliverables such as BOMs, drawings, and specification maps
  • Experience in test method development and validation
  • Knowledge of Class II/III medical device regulations
  • Prior experience supporting product or platform integration, including acquisition integration initiatives

About the Company

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Intellectt INC