Associate Product Development Engineer - Medical Devices

An Associate Product Development Engineer needed to join Gilero's team where we help bring life-enhancing products to market efficiently and effectively. Gilero is a trusted partner for medical and drug delivery device development, offering expertise in design, development, and manufacturing solutions. We have a passion for innovation and a commitment to excellence with a broad range of projects and technical expertise. Join our team and contribute to improving lives worldwide.

At Gilero, you will play a pivotal role on our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers. You will gain experience and learn how to support and 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. You will support the management of technical risks and ensure high-quality outcomes, ensuring seamless communication with customers, vendors and internal teams. You will work with senior engineers, developing excellence and promoting future success. The right candidate will have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.

Location: Carlsbad, CA

Responsibilities:
Support product development deliverables through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5)
Support technical risk tracking, providing engineering input, and seeking feedback and mentorship of senior engineers
Help support 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
Support project managers for smaller, technically oriented projects
Prepare documentation to support design history files and regulatory submissions
Support draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
Support delivery of project objectives and milestones
Support 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
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
Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)

Skills/Qualifications:
BS in Engineering or equivalent technical degree
0+ years relevant working experience in product development, intern or co-op experience preferred.
Medical device or combination product experience preferred
Understanding of good GDP
Exposure to ISO 14971, 13485 and CFR 21
Ability to support and document appropriate scenarios for rationale-based decisions versus testing- based approaches
Ability to author scientific/logic-based rationale
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 and Innovation of Excellence and Integrity
Productive in a fast-paced, entrepreneurial environment.
Commits to excellence and quality service to external and internal customers.
Adheres to 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), 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.
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