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.ResponsibilitiesAct as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiativesManage product development deliverables through the entire development lifecycle, with a focus on manufacturing transferSupport sustaining engineering activities for products in commercial manufacturingWrite 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 nonconformancesParticipate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processesSupport the quotation process for engineering projects and commercial manufacturingFacilitate design transfer of existing products to and from other manufacturing sitesTrack technical risk and provide engineering guidanceSeek feedback and mentorship from senior engineersHelp lead the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root causeCreate, 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 requirementsKeep project managers informed on technical projects variables and statusPrepare documentation to support design history files and regulatory submissionsAnalyze 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 DownSupport delivery of project objectives and milestonesParticipate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirementsSupport product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality EngineeringWrite and execute protocols for design verification and validationSupport test method development and validationOversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical buildsSupport investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality EngineeringInvestigate, evaluate, and research competitive devices and product materials/designsSkills/Qualifications:BS in Engineering or equivalent technical degree1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferredSkilled at transforming technical situations into well-defined project deliverablesUnderstanding of good GDPUnderstanding of the Phase Gate SystemExposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge baseAbility to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testingAbility to support and document appropriate scenarios for rationale-based decisions versus testing-based approachesAbility to author scientific/logic-based rationaleAwareness of pre-clinical validation and GLPAbility to review and understand technical drawings and GD&T to support development lifecycle Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)Excellent communication skills (oral and written)Personal Attributes:Meets Gilero Core Values:Collaboration embracing teamwork and transparency in our organization, partnering with our customers and vendorsIntegrity doing the right thing at all times; fair and trustworthy; always keeping the patient in mindInnovation open to new ideas, processes, and solutions; leveraging technology to creatively solve problemsExcellence delivering exceptional products and services with passion and prideComfortable and productive in a fast-paced, entrepreneurial environmentA self-starter seeking a career opportunity with potential for internal advancement, seekingresponsibility for core activities and providing high-quality service to internal and to external clientsCommitment to excellence and quality service to external and internal customersFollow established policies and procedures, while contributing to continuous improvementsEligibility To Work:Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.Gilero does not offer sponsorship for employment authorizations (work visas).We are an E-Verify employer and confirm work authorization for all new hires.Why work at Gilero?Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.Featured benefitsMedical insuranceVision insuranceDental insurance401(k)Paid maternity leavePaid paternity leaveDisability insurance