Senior Product Development Engineer - Medical Devices

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? Sanner America (formerly Gilero) is looking for a Senior Product Development Engineer for our Durham, NC Office. Join our mission-driven team driving innovative solutions for patients and customers. In this role you will champion the design, development, and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements. If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. As part of the Sanner Group, we share a global culture built on collaboration, transparency, agility, and shared success, united by one purpose: Protecting Health. Responsibilities Act as a technical lead, increasing the rigor of technical product development, with project oversight of products, accessories, and cross-functional initiatives.Manage product development deliverables of high complexity through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5).Track technical risk and provide engineering guidance.Provide feedback and mentorship to junior engineers.Lead the development team through technical risk retirement. Guide the team on technical risks through step-by-step simplification to discover root cause.Create, review, and release documents according to Sanner America’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements.Inform project managers and business development on technical projects variables in order to build accurate project budgets that include feasibility, prototyping, verification and validation.Act as project manager for smaller, technically oriented projects. Skills/Qualifications Able to work in the office 4 days a weekBS in Engineering or equivalent technical degree5+ years of product development experience in medical device, combination product or similar space preferredSkilled at transforming complex situations into well-defined project deliverablesAble to lead team to achieve difficult goals through step-by-step simplificationAble to convert complex questions into tasks to further drive simplification and clarificationUnderstanding of good GDPUnderstand the Phase Gate SystemHave deep ISO 14971, 13485 and CFR 21 Knowledge base; Experience with ISO 10993 a plusTranslate VOC (Voice of Customer) feedback into engineering design inputs and outputsCreate/draft clinically relevant User Requirements with minimal oversightAbility to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing.Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approachesAbility to author scientific/logic-based rationalePrepare 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 chartering and maintaining project objectives and milestones.Develop testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.Lead 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 validationLead test method development and validation, have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical buildsLead 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/designsUnderstanding of Pre-clinical validation and GLPAbility to review and understand technical drawings and GD&T to support development lifecycleAbility to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)Excellent communication skills (oral and written) Personal Attributes Demonstrates and consistently supports Sanner America Core Values of Collaboration, Innovation, Excellence, and IntegrityComfortable and productive in a fast-paced, entrepreneurial environmentA self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clientsCommitment to excellence and quality service to external and internal customersFollows established policies and procedures, while contributing to continuous improvements Eligibility To Work Ability to pass a pre-employment background checkApplicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.Sanner America does not offer sponsorship for employment authorizations (work visas).We are an E-Verify employer and confirm work authorization for all new hires Why Sanner America? Headquartered in Durham, North Carolina, Sanner America is the North American business of the Sanner Group and an end-to-end partner for medical devices, drug delivery systems, and healthcare packaging. Carrying forward the Gilero legacy of more than two decades of medical device design, development, and manufacturing, our teams take products from concept to commercialization. Our culture is built on collaboration, transparency, agility, and shared success, united by the Sanner Group purpose: Protecting Health. US locations include Carlsbad, CA; Chicago, IL; and Durham, Greensboro, and Pittsboro, NC, with additional operations in Mexico. Sanner America offers an annual bonus plan; three BCBS medical plans; dental and vision coverage; company-provided life insurance, short- and long-term disability; paid maternity and parental leave; a 401(k) match beginning the first month after hire with no vesting period; and access to LinkedIn Learning, with over 21,000 courses and certifications for personal and professional development. Become part of a team motivated by compassion and a shared commitment to making a meaningful impact on patients, caretakers, and consumers everywhere!