Job Summary
A leading orthopedic manufacturing company is seeking an experienced Senior Design Transfer Engineer to oversee the seamless transition of innovative medical devices from R&D to large-scale manufacturing. This role plays a crucial part in ensuring products meet the highest standards for regulatory and quality compliance and are launched efficiently into production. The ideal candidate will possess advanced technical skills, strong project management abilities, and a commitment to mentorship and team development, driving success across multiple cross-functional projects.
Key Responsibilities
- Design Transfer Management: Lead the end-to-end design transfer process for new medical devices, ensuring smooth integration from product design to scalable manufacturing.
- Cross-Functional Collaboration: Collaborate closely with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to develop, validate, and implement robust manufacturing processes.
- Project Management: Drive complex design transfer projects, using strategic project management skills to align resources, timelines, and budgets for optimal project execution.
- Quality & Regulatory Compliance: Ensure adherence to relevant regulatory and quality standards (e.g., FDA, ISO 13485) during the design transfer process, minimizing compliance risks.
- Mentorship & Team Development: Guide and mentor a team of engineers, fostering professional growth and a collaborative, innovative work environment.
- Process Improvement: Identify and implement continuous improvements in the design transfer process to enhance efficiency, reduce costs, and drive innovation.
- Documentation & Reporting: Maintain accurate, thorough documentation throughout the design transfer process, ensuring all activities meet internal and external audit requirements.
Qualifications
- Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; Master’s degree is preferred.
- Experience: 8+ years of experience in design transfer, manufacturing engineering, or related roles within the medical device or orthopedic manufacturing industry.
- Technical Skills: Advanced expertise in manufacturing processes, DFM/A (Design for Manufacturability/Assembly), and familiarity with medical device product development.
- Project Management: Proven experience managing complex projects and cross-functional teams, with strong organizational and problem-solving skills.
- Regulatory Knowledge: In-depth understanding of regulatory requirements and quality standards (e.g., FDA, ISO 13485) for medical devices.
- Communication & Leadership: Excellent communication, leadership, and team collaboration skills with a strong aptitude for guiding and developing engineering talent.
Preferred Skills
- Six Sigma or Lean Manufacturing certification.
- Experience with process validation and test method validation in a regulated environment.
- Proficiency with CAD and ERP systems.
This role is an exceptional opportunity to join a leading company in orthopedic manufacturing, providing a collaborative work environment with a focus on innovation and excellence. If you are a driven engineering professional passionate about bringing life-changing products to market efficiently and effectively, we invite you to apply.
