Reliability Engineer – Quality and Continuous Improvement - Medical Devices

Do you have a passion for continuous improvement? Are you a data-driven problem solver who loves applying six sigma principles, statistics, and reliability testing to real-world challenges? At Gilero, we design, develop, and manufacture innovative medical devices and combination products that directly improve patient lives. We’re looking for a Reliability Engineer to focus on quality and continuous improvement that will apply six sigma principles, statistical analysis, and advanced quality tools to ensure our processes and systems are efficient and meet the highest standards of safety, reliability, and performance.

In this role, you’ll be the six-sigma and statistical expert on cross-functional project teams, using Minitab, MATLAB, R, JMP, and other tools to design and analyze experiments, improve reliability and overall drive continuous improvement.

What You’ll Do

• Apply Six Sigma and Lean principles to drive continuous improvement across quality systems, manufacturing transfer, and reliability programs.
• Manage and continuously improve assigned quality system elements (CAPA, complaints, supplier management, audits, etc.).
• Lead root cause investigations with strong statistical rigor and implement corrective/preventive actions (CAPA).
• Serve as the quality and statistics lead in continuous improvement projects, reliability testing, and data-driven decision making. Applying Design On Experience (DOE) principles.
• Support design verification and validation activities, including test method development, protocol authoring, execution, and advanced data analysis. Applying a variety of variable-based testing strategies with small sample sizes and multiple sources of variance.
• Partner with R&D, manufacturing, and clients to support process validation (IQ/OQ/PQ) using statistical sampling plans and robust analysis.
• Partner with R&D, manufacturing, and clients to establish in-process inspection and incoming inspection plans
• Support regulatory submissions with statistically defensible data.
• Mentor engineers and team members on statistical methods, tools, and best practices.
• Conduct risk analysis (FMEA, FTA, etc.) and leverage statistical methods to proactively mitigate failure modes.

Minimum Qualifications

• Bachelor’s degree in engineering, statistics, or related scientific/technical field.
• 3 years in a regulated medical device, combination product, pharmaceutical, or other federally regulated development/manufacturing environment.
• Strong working knowledge of reliability testing methodologies, operating characteristic curves, and DOE.
• Proficiency in Minitab, JMP, MATLAB, R, or similar statistical software for experiment design, data analysis, and visualization.
• Experience with FDA 21 CFR Part 820, ISO 13485, and cGMP standards.
• Hands-on experience with risk analysis and quality systems (CAPA, audits, complaints, supplier management, etc.).
• Excellent communication skills with the ability to present statistical results to technical and non-technical stakeholders.

Preferred Qualifications

• Master’s or advanced degree in Engineering, Statistics, or Quality.
• ASQ CRE (strongly preferred), CQE or related certification.
• Lean and/or Six Sigma Certification (Black Belt strongly preferred)
• Project management experience in medical device development from concept to commercialization.
• Demonstrated success applying statistical methods in pre-clinical through commercial phases.
• Experience working with small sample sizes.
• Experience working with electromechanical products.

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence
• Comfortable and productive in a fast-paced, entrepreneurial environment
• Commitment to excellence and quality service to external and internal customers
• Commitment to established policies and procedures, while contributing to continuous improvements

Eligibility To Work

Candidates must be legally eligible to work in the US without requiring current or future sponsorship. 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.