Director, Quality Engineering

SI-BONE•San Jose, CA

About The Position

The Director of Quality Engineering leads the technical quality function supporting product development, manufacturing, suppliers, and sustaining engineering. This role 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. It is a technically engaged leadership position requiring substantial engineering depth, strong statistical capabilities, and sound judgment. The Director challenges assumptions, assesses the strength of technical evidence, and guides practical solutions—not merely completion of quality documentation. The Director defines Quality Engineering strategy across new product development, design transfer, and sustaining activities; provides technical oversight of design assurance, verification and validation, manufacturing and inspection controls, supplier quality, investigations, improvement, and quality-process software assurance; and develops the team's capabilities. The role also contributes technical evidence and Quality Engineering input for regulatory submissions, inquiries, and audits. The Director may place affected product or processing activities on hold when there is a reasonable concern about product conformity, safety, or compliance, and must promptly escalate concerns through appropriate channels. SI-BONE is a publicly traded medical device company focused on minimally invasive sacropelvic solutions and improving care for patients with sacroiliac pelvic conditions. Its iFuse Implant System has been used in over 90,000 procedures. The company describes its culture as agile, creative, and team-oriented. The position's salary range is $210,000–$235,000, with potential bonus and stock supplemental pay.

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, including 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 and 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.
Ability and responsibility to promptly escalate reasonable concerns regarding product conformity, safety, or compliance through appropriate channels.
Conduct business honestly, ethically, and lawfully in accordance with the company Code of Conduct and applicable 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, if assigned, inspection personnel; establish responsibilities, technical expectations, priorities, and development plans.
Define Quality Engineering strategy for new product development, design transfer, and sustaining activities, and allocate resources according to 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 to ensure engineering activities align with quality-system processes and are controlled, traceable, and documented.
Partner with R&D to establish measurable product requirements and methods to demonstrate 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; oversee applicable mechanical, functional, 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 manufacturing processes and supplier capabilities can consistently meet 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.
Oversee inspection methods, sampling plans, acceptance criteria, and critical controls, supported by appropriate validation and measurement-system analysis.
Evaluate process capability, stability, and 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 those concerns through appropriate Quality, Regulatory, and management channels.
Conduct business honestly, ethically, and lawfully, consistent with SI-BONE’s Code of Conduct and applicable company policies.