What are the responsibilities and job description for the Medical Device Engineer position at Collabera?
Job Summary:
An industry-leading healthcare technology organization is seeking a Medical Device Engineer III to support lifecycle management and on-market design changes for combination and consumable medical devices. This role will focus on product design support, supplier-driven engineering changes, Design History File (DHF) maintenance, regulatory compliance, and cross-functional collaboration. The ideal candidate has experience in medical device or pharmaceutical product development and a strong understanding of global quality and regulatory requirements.
Key Responsibilities:
• Lead engineering activities supporting on-market product changes and product lifecycle management for medical devices.
• Execute supplier-driven design changes while ensuring product quality, compliance, and manufacturing readiness.
• Maintain and update Design History File (DHF) documentation and product traceability throughout the product lifecycle.
• Perform engineering test execution, data analysis, deviation investigations, and technical report preparation.
• Review technical documentation to ensure compliance with applicable regulatory and quality requirements.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners.
• Support manufacturing activities by resolving product design issues and implementing engineering improvements.
• Drive process standardization and continuous improvement initiatives to improve development and product support efficiency.
• Communicate project status, technical challenges, and implementation strategies to internal stakeholders and external vendors.
• Ensure engineering activities comply with global medical device regulations and industry standards.
Required Qualifications:
• Bachelor's degree in Bioengineering, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• At least three years of experience in medical device or pharmaceutical product development.
• Experience with Design History File (DHF) management and product lifecycle documentation.
• Knowledge of supplier change management and on-market product support.
• Experience executing engineering testing, deviation investigations, data review, and technical report writing.
• Working knowledge of global medical device regulations including MDR, ISO 13485, ISO 14971, and ISO 10993.
• Familiarity with FDA medical device regulations and quality system requirements.
• Excellent written, verbal, and cross-functional communication skills.
• Strong organizational skills with the ability to manage multiple priorities.
Preferred Qualifications:
• Master's degree in an engineering or scientific discipline.
• Experience with combination products or consumable medical devices.
• Experience supporting both medical device and pharmaceutical development programs.
• Knowledge of design controls, risk management, and product verification activities.
• Experience driving continuous improvement or process standardization initiatives.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $50/hr to $55/hr
Salary : $50 - $55