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 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.
Leadership and Communication - Ability to balance technical rigor, risk, timelines, and business needs without compromising product quality, moving readily 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.
Preferred Qualifications - 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.
Quality Authority and Professional Conduct The Director has the authority to place affected product or processing activities on hold when there is a reasonable concern regarding product conformity, safety, or compliance, and is responsible for promptly escalating those concerns through the appropriate Quality, Regulatory, and management channels.
The Director conducts business honestly, ethically, and lawfully, consistent with SI-BONE's Code of Conduct and applicable company policies. SI-BONE does not tolerate retaliation for good-faith reporting of suspected violations.
Salary range: $210,000 - $235,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.
Supplemental pay: bonus and stock
There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.
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