Design Transfer Engineer – Medical Devices

Do you have a passion for helping design and manufacture innovative medical and drug delivery devices that can improve lives? At Gilero’s Pittsboro, NC location, we are looking for a Design Transfer Engineer to help lead our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers.

Design Transfer Engineers draw on experience to oversee and champion the development and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

In this role, you would manage technical risks and ensure high-quality outcomes, ensuring seamless collaboration with customers, vendors, and internal teams. You would also mentor junior engineers, promoting excellence and future success. The work of a Senior Design Transfer Engineer should have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.

• Act as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiatives.
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer.
• Support sustaining engineering activities for products in commercial manufacturing.
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ).
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances.
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.>
  
  Support the quotation process for engineering projects and commercial manufacturing.
• Facilitate design transfer of existing products to and from other manufacturing sites.
• Track technical risk and provide engineering guidance.
• Seek feedback and mentorship from senior engineers.
• Help lead the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root cause.
• Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements.
• Keep project managers informed on technical projects variables and status.
• Prepare documentation to support design history files and regulatory submissions.
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals).
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down.
• Support delivery of project objectives and milestones.
• Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.
• Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering.
• Write and execute protocols for design verification and validation.
• Support test method development and validation.
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds.
• Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering.
• Investigate, evaluate, and research competitive devices and product materials/designs.

• BS in Engineering or equivalent technical degree.
• 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred.
• Skilled at transforming technical situations into well-defined project deliverables.
• Understanding of good GDP.
• Understanding of the Phase Gate System.
• Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base.
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set…