Associate Design Transfer Engineer – Medical Devices

Associate Design Transfer Engineer – Medical Devices

Job Purpose:

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 an Associate 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.

Our Associate Design Transfer Engineers play a pivotal role on our team, supporting the late‑stage development and transfer to production of medical devices and combination devices. They focus on verification, validation, and design history file (DHF) development to state‑of‑the‑art requirements, manage technical risks, and ensure high‑quality outcomes while communicating seamlessly with customers, vendors, and internal teams.

Responsibilities:

• Support product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer.
• Assist with IQ, OQ, and PQ activities/executions.
• Support technical risk tracking, provide engineering input, and seek feedback and mentorship from senior engineers.
• Help support the development team through technical risk retirement, simplifying steps to discover root cause.
• Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project, and develop manufacturing test methods and inspections to meet state‑of‑the‑art requirements.
• Keep project managers informed of technical project variables and status.
• Support project managers by leading smaller, technically oriented projects.
• 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).
• Support draft risk documentation through understanding of risk, risk analysis, and risk burn‑down.
• Support delivery of project objectives and milestones.
• Support 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.
• 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.

Skills / Qualifications:

• BS in Engineering or equivalent technical degree.
• 1+ years of relevant working experience in product development (intern or co‑op experience acceptable).
• Medical device or combination product experience preferred.
• Understanding of good GDP.
• Exposure to ISO 14971, ISO 13485, and CFR 21.
• Ability to support and document appropriate scenarios for rationale‑based decisions versus testing‑based approaches.
• Ability to author scientific/logic‑based rationale.
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc.).
• Excellent communication skills (oral and written).

Personal Attributes:

• Collaboration – embracing teamwork and transparency, partnering with customers and vendors.
• Integrity – doing the right thing at all times; fair, trustworthy, keeping the patient in mind.
• Innovation – open to new ideas, processes, and solutions, leveraging technology to creatively solve problems.
• Excellence – delivering exceptional products and services with passion and pride.
• Comfortable and productive in a fast‑paced, entrepreneurial environment.
• Self‑starter seeking internal advancement, responsible for core activities, and providing high‑quality service to internal and external clients.
• Commitment to excellence and quality service to customers.
• Follow established policies and procedures while contributing to continuous improvements.

Eligibility to Work:

• Applicants must be permanently authorized to work in the United States…