Senior Product Development Engineer - Medical Devices

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 Gilero’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 week BS in Engineering or equivalent technical degree 5+ years of product development experience in medical device, combination product or similar space preferred Skilled at transforming complex situations into well-defined project deliverables Able to lead team to achieve difficult goals through step-by-step simplification Able to convert complex questions into tasks to further drive simplification and clarification Understanding of good GDP Understand the Phase Gate System Have deep ISO 14971, 13485 and CFR 21 Knowledge base; Experience with ISO 10993 a plus Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs Create/draft clinically relevant User Requirements with minimal oversight Ability 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 approaches Ability to author scientific/logic-based rationale 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 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 Engineering Write and execute protocols for design verification and validation Lead 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 builds Lead 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 Understanding of Pre-clinical validation and GLP Ability 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 vendors; Integrity- doing the right thing at all times; fair and trustworthy; always 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 A 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 clients Commitment to excellence and quality service to external and internal customers Follows established policies and procedures, while contributing to continuous improvements Eligibility To Work Ability to pass a pre-employment background check 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 Durham, Greensboro, and Pittsboro. You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.