This role bridges the gap between design and manufacturing in a medical device company. You’ll be responsible for ensuring new products meet specifications, regulations, and are successfully transferred to production.

Key Responsibilities:

• Validation and Verification Leadership: You’ll plan, execute, and document all validation and verification activities. This ensures medical devices meet design requirements and regulatory standards.
• Design Transfer Management: You’ll oversee the seamless transition of product designs from the development phase to manufacturing, safeguarding design integrity throughout the process.
• Quality Assurance Collaboration: Working with QA teams, you’ll help develop and maintain quality systems that adhere to industry standards like ISO and FDA regulations.
• Regulatory Compliance Expertise: You’ll stay updated on regulatory requirements, particularly the FDA’s PMA process, and ensure all validation and design transfer activities comply with these regulations.
• Cross-Functional Teamwork: Effective communication and collaboration are key. You’ll work closely with R&D, manufacturing, and other departments to ensure project success.
• Comprehensive Documentation: You’ll ensure all validation and design transfer activities are thoroughly documented according to regulatory and company standards.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in validation and design transfer within the medical device industry.
• Solid understanding of CE and FDA regulations, along with ISO standards relevant to medical devices.
• Proven experience with the PMA approval process is a major plus.
• Excellent project management skills and the ability to lead cross-functional teams are essential.

Preferred Qualifications:

• An advanced degree in a relevant field.
• Experience working with endovascular devices or similar medical device categories.
• Familiarity with a wide range of global regulatory standards and requirements.

In essence, this Senior Validation/Design Transfer Specialist is a critical bridge between the creative and productive sides of medical device development.