Senior Product Development Engineer – Medical Devices Position Available In Durham, North Carolina

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero’s Durham, NC office, we are looking for a Senior Product Development Engineer to 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. Join us and be part of a company that values innovation, integrity, and excellence! 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:

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).

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 customer Follows established policies and procedures, while contributing to continuous improvements Excellent communication skills (oral and written) 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 continue to grow at a rapid pace. US locations include NC locations in Durham, Greensboro, and Pittsboro along with offices in Carlsbad, CA and Chicago, IL. 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 you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.