Job 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 Senior 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.

Senior 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 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, with a focus on manufacturing transfer
• Lead 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
• Support the quotation process for engineering projects and manufacturing
• Lead design transfer of existing products to and from other manufacturing sites
• Provide feedback and mentoring 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
• Contribute to developing design transfer tools and processes and train others to use those systems
• 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
• 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)
• Lead investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering

Skills/Qualifications:

• US Citizen or Green card holder
• 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
• Understanding of good GDP
• Deep knowledge base of ISO 14971, 13485 and CFR 2; Experience with ISO 10993 a plus
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specifications through thought experiments and empirical testing
• Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Understanding of Pre-clinical validation and GLP

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

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), 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.

Featured benefits

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

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