Senior Product Development Engineer - Medical Devices

GILERO•Durham, NC

1d•Hybrid

About The Position

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero/Sanner'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!

Requirements

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.
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)
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
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

Nice To Haves

Experience with ISO 10993 a plus

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.
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