Director of Technical Operations

AuST Group is both a premier medical device design and development firm and a high-volume manufacturer of components and finished devices. We bring broad experience in minimally invasive technologies and deep expertise in cardiovascular catheters. "AuST" is a name symbolizing the gold (Au) standard (ST). We strive to deliver the gold standard in everything we do. We are seeking a Technical Operations Leader to drive operational excellence, technical strategy, and cross-functional leadership across manufacturing, engineering, and digital systems. This role is accountable for process technology, equipment reliability, throughput optimization, and technical problem-solving while fostering a culture of continuous improvement and employee engagement. Role Overview The Tech Ops Leader provides strategic and hands-on leadership for technical operations, bridging product development, process engineering, manufacturing execution, and quality assurance. This position owns the technical readiness of production systems, leads complex investigations, and ensures alignment between operational performance and business objectives. Key Responsibilities Strategic Leadership and Operations Management Define and execute technical operations strategy aligned with site goals for safety, quality, delivery, cost, and scalability. Own operational performance metrics (OEE, yield, throughput, scrap, downtime) and drive initiatives to achieve and exceed targets. Lead cross-functional teams (engineering, automation, technology) to optimize processes and resolve systemic issues. Champion process safety, risk management, and operational discipline across all manufacturing activities.​ Develop and manage technical operations budget, capital plans, and resource allocation to support business growth. Process Technology and Engineering Excellence Oversee process technology transfer, scale-up, and new product introductions from development through validated production. Lead new equipment and technology evaluations, justifications, installations, and qualifications to improve capability and capacity. Continuously assess operability of manufacturing processes and equipment; implement improvements to reduce failure modes and increase reliability.​ Ensure process control strategies, validated ranges, and critical parameters are maintained and optimized for performance and compliance. Provide technical expertise to unlock throughput gains through innovation in processes, tooling, automation, and ways of working.​ Problem Solving, Investigations, and Continuous Improvement Lead complex technical investigations (deviations, CAPAs, NCRs, yield loss) to root cause using structured problem-solving methods (8D, DMAIC, PDCA).​ Drive containment, corrective action, and preventive action plans to closure with accountability and timeliness. Deploy lean manufacturing, Six Sigma, and continuous improvement tools to eliminate waste, reduce variation, and improve flow.​ Facilitate kaizen events, WSVA assessments, and gemba walks to engage teams and sustain operational improvements.​ Quality, Compliance, and Regulatory Interface Ensure technical operations comply with

ISO 13485, ISO 14971, FDA

QSR, or other applicable regulatory and quality standards.​ Lead technical discussions with customers, auditors, and regulatory agencies during site inspections, submissions, and product approvals.​ Support change control, risk assessment (pFMEA, process FMEA), and design control activities as technical authority. Maintain technical documentation (process validation, equipment qualification, SOPs, master batch records) in compliance with GMP/QSR. People Leadership and Development Recruit, develop, and retain high-performing technical operations team; provide coaching, mentorship, and career development. Create a positive, engaging work environment that fosters collaboration, innovation, accountability, and psychological safety. Lead and facilitate technical meetings, project reviews, and daily management routines with clear agendas, actions, and accountability. Champion operational excellence behaviors including 6S, standard work, visual management, and respect for people.​ Provide thought leadership on emerging technologies, industry trends, and best practices to keep the organization competitive.​ Stakeholder Management and Communication Serve as primary technical liaison for customers, suppliers, and internal stakeholders on operational performance and technical capabilities. Communicate complex technical information clearly and effectively to diverse audiences (leadership, operators, customers, auditors). Align cross-functional teams on priorities, deliverables, and timelines; manage expectations with transparency and integrity. Influence and drive change across organizational boundaries through data-driven decision-making and collaborative leadership.​ Required Qualifications Bachelor's degree in Engineering, Operations Management, or related technical field; advanced degree (MS, MBA) preferred. 10+ years of progressive experience in technical operations, manufacturing engineering, or process engineering in a regulated manufacturing environment. 5+ years of people leadership experience managing technical teams and driving operational performance. Deep knowledge of manufacturing processes, equipment, quality systems, and continuous improvement methodologies (Lean, Six Sigma). Proven ability to lead complex investigations, solve systemic problems, and implement sustainable corrective actions. Strong project management skills with experience leading technology transfers, capital projects, and process improvements. Excellent communication, influence, and stakeholder management skills across all organizational levels. Proof of eligibility to work in the United States must be provided if selected for hire. Preferred Qualifications Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.​ Familiarity with

ISO 13485, FDA

QSR, GMP, and validation requirements (IQ/OQ/PQ). Lean Six Sigma Black Belt, PMP, or equivalent certification.​ Experience with

MES, SCADA, ERP

systems, and data analytics tools.​

Employment Details Job Type:

Full-time Benefits:

401(k), 401(k) matching, health insurance, dental insurance, vision insurance, health savings account, life insurance, paid time off, retirement plan

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Relocation assistance Retirement plan Vision insurance

Experience:

Technical Operations, Manufacturing or Process Engineering :

10 years (Preferred) Ability to

Commute:

West Valley City, UT 84119 (Preferred)

Work Location:

In person