Director, Quality Engineering

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.

• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo.

• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

Position Summary

The Director of Quality Engineering leads the technical quality function supporting product development, manufacturing, suppliers, and sustaining engineering. The Director manages the Quality Engineering team and partners with Research and Development, Operations, Supply Chain, Regulatory Affairs, and other Quality functions to translate product requirements and risks into effective design, manufacturing, supplier, and inspection controls.

This is a technically engaged leadership position requiring substantial engineering depth, strong statistical capabilities, and sound judgment. The Director is expected to challenge assumptions, assess the strength of technical evidence, and guide practical solutions, not just oversee completion of quality documentation.

Key Responsibilities

Technical Leadership and Team Development

• Manage and develop the Quality Engineering team, and inspection personnel if assigned; establish clear responsibilities, technical expectations, priorities, and development plans.

• Define the Quality Engineering strategy across new product development, design transfer, and sustaining activities, and allocate resources according to product risk, business priorities, and project needs.

• Provide independent quality judgment in cross-functional decisions, clearly communicating technical risks, evidence gaps, and recommended actions.

• Partner with the Senior Director of Quality and the Quality Systems function so that engineering activities align with quality-system processes and are appropriately controlled, traceable, and documented.

Product Development and Design Assurance

• Partner with R&D to establish clear, measurable product requirements and appropriate methods for demonstrating that those requirements are met.

• Lead Quality Engineering contributions to product risk management, including identification of failure modes, evaluation of risk controls, and assessment of residual risk.

• Guide verification and validation strategies, including test methods and test-method validation, acceptance criteria, and worst-case configurations; provide technical oversight of mechanical and functional testing and, as applicable, biocompatibility, cleaning, sterilization, packaging, and distribution testing.

• Review technical protocols, results, deviations, and reports for scientific rigor, appropriate statistical treatment, and defensible conclusions.

• Support design transfer by ensuring that manufacturing processes and supplier capabilities can consistently achieve product requirements.

• Evaluate design, material, manufacturing, supplier, and quality-process software changes to determine their effects on product performance and risk, and the qualification, validation, or testing required.

Manufacturing, Inspection, and Process Quality Engineering

• Lead Quality Engineering support for manufacturing and sustaining activities, including contract manufacturing and risk-based process qualification and validation.

• Provide technical oversight of inspection methods, sampling plans, acceptance criteria, and critical controls, supported by appropriate validation and measurement-system analysis.

• Evaluate process capability, stability, and sources of variation; lead engineering improvements to reduce recurring failures and improve product conformity and manufacturing performance.

• Lead technical evaluation and significant nonconforming-product disposition decisions using objective evidence and risk assessment.

Supplier Quality Engineering

• Lead the technical quality interface with suppliers and contract manufacturers, partnering with Supply Chain and Operations to improve supplier quality performance.

• Assess supplier capabilities, manufacturing controls, and validation approaches through performance data, technical assessments, and risk-based supplier audits; address capability gaps.

• Establish qualification strategies for new suppliers and significant supplier changes.

Statistical Knowledge, Investigations, and Improvement

• Establish scientifically sound statistical methods for product testing, process qualification, inspection, and performance monitoring, including sample sizes and acceptance criteria justified by the engineering question, risk, data characteristics, and required strength of evidence.

• Apply experimental design, variance analysis, and other appropriate methods to understand product and process behavior.

• Lead or oversee complex investigations of product failures, manufacturing and supplier defects, and adverse quality trends, using structured problem-solving, data analysis, and targeted experiments to establish root cause.

• Provide engineering leadership for product, process, and supplier corrective actions, including evaluation of their effectiveness.

• Translate complaint, nonconformance, inspection, and supplier data into improvements, and establish meaningful performance measures to prioritize improvement efforts.

Quality-Process Software and Technical Compliance Support

• Provide risk-based technical oversight of validation or assurance activities for software used in quality processes, including intended-use assessment, requirements definition, testing strategy, and evaluation of results.

• Provide technical evidence and Quality Engineering input for regulatory submissions, regulatory inquiries, and internal and external audits.

Required Qualifications:

Education and Experience

• Bachelor’s degree in engineering or a closely related technical discipline.

• At least 10 years of progressively responsible, hands-on experience in medical-device quality engineering or closely related engineering roles, supporting both new product development and sustaining or manufacturing activities.

• Demonstrated experience managing engineering personnel, setting technical direction, and developing team capabilities.

• Experience working with external suppliers or contract manufacturers on technical qualification, process controls, investigations, and improvements.

Engineering and Statistical Expertise

• Strong command of design controls, risk management, verification and validation, design transfer, process validation, and supplier quality engineering, with the ability to critically evaluate technical evidence and investigate complex failures.

• Substantial applied statistical experience, including sampling and sample-size justification, inference, process capability and control, measurement-system analysis, experimental design, and reliability methods.

• Proficiency with statistical software; ability to independently analyze