Quality Engineer – Statistical & Reliability for Medical Devices

Are you a data-driven problem solver who loves applying statistics, Design of Experiments (DOE), 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 Senior Quality Design Engineer with expertise in statistical analysis, Six Sigma methods, and advanced quality tools to ensure our products meet the highest standards of safety, reliability, and performance.

In this role, you’ll be the statistical and quality expert on cross-functional project teams, using Minitab, MATLAB, R, JMP, and other tools to design and analyze experiments, develop verification and validation strategies, and drive continuous improvement. Your insights will directly influence product design decisions, risk reduction strategies, and qualification activities—ensuring our devices are built with precision and deliver consistent results.

What You’ll Do

• Serve as the quality and statistics lead in product development projects, guiding teams in applying DOE, reliability testing, and data-driven decision making.
• Translate user needs into measurable product requirements and statistically sound specifications.
• Lead design verification and validation activities, including test method development, protocol authoring, execution, and advanced data analysis.
• Conduct risk analysis (FMEA, FTA, etc.) and leverage statistical methods to proactively mitigate failure modes.
• Partner with R&D, manufacturing, and clients to support process validation (IQ/OQ/PQ) using statistical sampling plans and robust analysis.
• Apply Six Sigma and Lean principles to drive continuous improvement across quality systems, manufacturing transfer, and reliability programs.
• Lead root cause investigations with strong statistical rigor and implement corrective/preventive actions (CAPA).
• Manage and continuously improve assigned quality system elements (CAPA, complaints, supplier management, audits, etc.).
• Maintain accurate, complete Design History Files and support regulatory submissions with statistically defensible data.
• Mentor engineers and team members on statistical methods, tools, and best practices.

Minimum Qualifications

• Bachelor’s degree in engineering, statistics, or related scientific/technical field.
• 3+ years in a regulated medical device, combination product, or pharmaceutical development/manufacturing environment.
• Strong working knowledge of DOE, Six Sigma (Green/Black Belt preferred), and reliability testing methodologies.
• 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, cGMP, and IEC 60601 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 CQE, Six Sigma Black Belt, or related certification.
• Project management experience in medical device development from concept to commercialization.
• Demonstrated success applying statistical methods in pre-clinical through commercial phases.

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.