Engineer Medical Device Development

Dice is the leading career destination for tech experts at every stage of their careers. Our client, New York Technology Partners, is seeking the following. Apply via Dice today!

Job Summary

We are seeking an experienced Senior Engineer Medical Device Development with strong hands-on expertise across the endtoend medical device product development lifecycle, including design, documentation, verification & validation (V&V), and regulatory compliance.

The ideal candidate will have deep experience working in regulated medical device environments and hands-on proficiency with QMS, PLM, requirements, and CAD tools such as MasterControl, Arena, Jama, and SolidWorks, in alignment with FDA, ISO 13485, and applicable IEC standards.

Required Qualifications

Education

• Bachelor s or Master s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
  
  

Experience

• 5 10 years of hands-on experience in medical device development.
• Proven experience working in regulated (GxP) environments.
• Direct, hands-on experience with:
• MasterControl
• Arena PLM
• Jama
• SolidWorks
• Experience with design controls and risk management (ISO 14971).
  
  

Technical Skills

• Strong understanding of:
• Design Controls & DHF management
• Requirements traceability
• Verification & Validation (V&V)
• Change control and configuration management
• Familiarity with tools such as Altium, Windchill, Teamcenter, Minitab, IBM DOORS, or Veeva Vault is a plus.
  
  

Soft Skills & Competencies

• Strong analytical and problem-solving skills
• Excellent documentation and technical writing abilities
• Ability to work independently and in cross-functional teams
• Strong communication skills with stakeholders and leadership
• High attention to detail with a compliance-focused mindset
  
  

Key Responsibilities

Product Development & Engineering

• Lead and contribute to medical device design and development activities from concept through commercialization.
• Develop, review, and maintain design inputs, outputs, specifications, and technical documentation aligned with user needs and regulatory requirements.
• Perform CAD modeling, design updates, and engineering drawings using SolidWorks or equivalent mechanical CAD tools.
• Support design verification, validation, and risk management activities throughout the product lifecycle.
  
  

Quality & Regulatory Compliance

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards.
• Author, review, and maintain Design History File (DHF), Device Master Record (DMR), and related technical documentation.
• Support internal and external audits, regulatory inspections, and submission readiness activities.
• Participate in change management, deviation investigations, and CAPA processes.
  
  

Tools & Systems (Hands-On)

• Actively use and manage documentation and records within:
• MasterControl QMS, document control, training, change management
• Arena PLM BOMs, ECOs, configuration, and product lifecycle management
• Jama requirements management and traceability matrices
• SolidWorks mechanical design and engineering drawings
• Ensure endtoend traceability across requirements, design, risk, and test artifacts.
  
  

Cross-Functional Collaboration

• Work closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams.
• Collaborate with suppliers and manufacturing partners to support DFM/DFA and production transfer.
• Support technology transfer, scaleup, and manufacturing readiness activities.