Director, Quality Engineering

SI-BONE, Inc•San Jose, CA

2d•$210,000 - $235,000

About The Position

The Director of Quality Engineering leads SI-BONE’s 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 merely oversee completion of quality documentation. The role has authority to place affected product or processing activities on hold when there is reasonable concern regarding product conformity, safety, or compliance, and is responsible for promptly escalating concerns through appropriate channels. The Director is expected to conduct business honestly, ethically, and lawfully, consistent with SI-BONE’s Code of Conduct and applicable company policies.

Requirements

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.
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 data, critically review others’ analyses, and interpret assumptions, uncertainty, and engineering significance.
Working knowledge of applicable medical-device requirements and standards, including 21 CFR Part 820, ISO 13485, ISO 14971, and the EU Medical Device Regulation.
Experience with risk-based validation or assurance of quality-process software.
Ability to balance technical rigor, risk, timelines, and business needs without compromising product quality, moving between detailed analysis and broader organizational priorities.
Demonstrated effectiveness influencing cross-functional teams, resolving technical disagreements using evidence, and explaining complex technical issues and recommendations to senior leadership.
Strong prioritization, accountability, and follow-through.
Conduct business honestly, ethically, and lawfully, consistent with SI-BONE’s Code of Conduct and applicable company policies.

Nice To Haves

Experience with orthopedic implants, surgical instruments, and associated manufacturing processes, including applicable ASTM and ISO test standards.
Experience with sterile products, packaging validation, cleaning validation, and sterilization.
Experience with dimensional metrology, geometric dimensioning and tolerancing, and inspection of precision-manufactured components.
Quality engineering experience with human tissue products, particularly process characterization, variability assessment, test-method development, validation, and product acceptance criteria.
ASQ Certified Quality Engineer or comparable certification.
Advanced degree in engineering, statistics, or a related technical discipline.

Responsibilities

Manage and develop the Quality Engineering team, and inspection personnel if assigned; establish 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, communicating technical risks, evidence gaps, and recommended actions.
Partner with the Senior Director of Quality and Quality Systems so engineering activities align with quality-system processes and are appropriately controlled, traceable, and documented.
Partner with R&D to establish measurable product requirements and methods for demonstrating that requirements are met.
Lead Quality Engineering contributions to product risk management, including failure-mode identification, evaluation of risk controls, and assessment of residual risk.
Guide verification and validation strategies, including test methods and their validation, acceptance criteria, and worst-case configurations; provide technical oversight of applicable product testing.
Review technical protocols, results, deviations, and reports for scientific rigor, appropriate statistical treatment, and defensible conclusions.
Support design transfer by ensuring manufacturing processes and supplier capabilities can consistently achieve product requirements.
Evaluate design, material, manufacturing, supplier, and quality-process software changes for effects on product performance and risk, and determine required qualification, validation, or testing.
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.
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 using performance data, technical assessments, and risk-based supplier audits; address capability gaps.
Establish qualification strategies for new suppliers and significant supplier changes.
Establish scientifically sound statistical methods for product testing, process qualification, inspection, and performance monitoring, including justified sample sizes and acceptance criteria.
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 effectiveness.
Translate complaint, nonconformance, inspection, and supplier data into improvements, and establish meaningful performance measures to prioritize improvement efforts.
Provide risk-based technical oversight of validation or assurance 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.
Place affected product or processing activities on hold when there is reasonable concern regarding product conformity, safety, or compliance, and promptly escalate concerns through appropriate channels.
Conduct business honestly, ethically, and lawfully, consistent with SI-BONE’s Code of Conduct and applicable company policies.