Design Transfer Engineer – Medical Devices - Pittsboro - Gilero, A Sanner Group Company

Description

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.

Responsibilities

• Act as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiatives
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
• Support sustaining engineering activities for products in commercial manufacturing
• Write 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 nonconformances
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes
• Support the quotation process for engineering projects and commercial manufacturing
• Facilitate design transfer of existing products to and from other manufacturing sites
• Track technical risk and provide engineering guidance
• Seek feedback and mentorship from senior engineers
• Help lead the development team through technical risk retirement. Support 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
• Keep project managers informed on technical projects variables and status
• 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 delivery of project objectives and milestones
• Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements
• Support 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
• Support test method development and validation
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Support 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

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred
• Skilled at transforming technical situations into well-defined project deliverables
• Understanding of good GDP
• Understanding of the Phase Gate System
• Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing
• Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Awareness 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
• Follow established policies and procedures, while contributing to continuous improvements

Eligibility 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 benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Disability insurance