Qualifications

• B.S. or M.S. in Engineering or related discipline
• 5-10 years of experience in a regulated medical device or combination product environment
• Strong familiarity with combination products and drug delivery systems
• In-depth knowledge of design controls and DHF management
• Experience in risk management according to ISO 14971
• Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820
• Strong technical writing, communication, and organizational skills
• Experience with JAMA and Windchill software
• Ability to manage multiple projects in a fast-paced environment

Responsibilities

• Author and maintain design control documentation for combination drug-device and biologic products
• Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle
• Support product development and technology transfer from early development to manufacturing
• Translate user needs into functional requirements and design outputs
• Develop specifications and support verification activities
• Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA
• Contribute to requirements management and quality systems to support development activities

Benefits

• Opportunities for professional development and advancement
• Access to cutting-edge technology in medical device design
• Participation in a collaborative and innovative team environment
• Support for continuous learning and skills enhancement
• Flexible working environment that promotes work-life balance