Director, PMO & Operational Excellence

Director, PMO & Operational Excellence

Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in the Salt Lake City suburb of Draper, Utah. Our primary product focus is total hip and knee replacement. We are passionate about designing and manufacturing innovative, clinically proven products using the latest material science and technology.

As a PMO Director, you will be responsible for establishing and leading the Project Management Office (PMO) to support the company’s strategic objectives in orthopedic design, development, and manufacturing. This role will focus on driving the adoption of lean manufacturing practices, optimizing project execution through the Gateway (stage-gate) process, and fostering cross-functional collaboration to ensure the on-time delivery of products that meet Ortho Development's high-quality standards. This role is also responsible for adoption and administration of the Company’s project management software. The ideal candidate is a strategic thinker with a proven track record in project management and lean methodologies within the medical device industry.

Location: Onsite - Draper, UT

Schedule: Monday- Friday

Principal Responsibilities

Lean Manufacturing Adoption:

• Champion the implementation of lean manufacturing methodologies across production processes to optimize efficiency, reduce waste, and ensure high product quality.
• Develop and deliver training programs to foster a culture of continuous improvement and lean thinking among teams.
• Monitor and report on key performance indicators (KPIs) related to lean initiatives, such as cycle time reduction and cost savings.

Stage-Gate Project Oversight:

• Oversee the end-to-end stage-gate process for new product development, from concept to commercialization.
• Ensure projects adhere to defined milestones, budgets, quality standards, and timelines while meeting regulatory and quality standards (e.g., FDA, ISO 13485).
• Facilitate cross-functional stage-gate reviews, ensuring alignment on project deliverables and risk mitigation strategies.
• Provide regular project status updates including risk assessments and resource allocation needs as requested by senior leadership.

PMO Leadership and Strategy:

• Build and lead a high-performing PMO team, providing mentorship, training, and clear direction to project managers and support staff.
• Establish and maintain standardized project management frameworks, tools, and best practices to enhance project execution.

Cross-Functional Collaboration:

• Partner with Marketing, R&D and engineering teams to align product design with manufacturing capabilities and market needs.
• Work closely with quality and regulatory teams to ensure compliance with industry standards and regulations.
• Collaborate with supply chain and operations to streamline production planning and resource allocation.
• Collaborate with cross-functional teams to identify and eliminate non-value-added activities, streamline workflows, and promote a lean culture.

Continuous Improvement:

• Identify opportunities to enhance PMO processes, tools, and metrics to drive efficiency and scalability.
• Leverage data analytics to assess project performance and inform strategic decision-making.
• Perform other job-related duties as assigned

Experience and Qualifications

• Bachelor's degree in engineering, business, operations management, or a related field; advanced degree (MBA, MS) preferred.
• 8 years of experience in project or program management, with at least 3 years in a leadership role within medical device, orthopedics, or a related manufacturing industry.
• Proven expertise in lean manufacturing principles and methodologies (e.g., Six Sigma, Kaizen); certification (e.g., Lean Six Sigma Black Belt) is a plus.
• Strong knowledge of stage-gate product development processes and medical device regulations (e.g., FDA, ISO 13485).
• Exceptional leadership and communication skills, with the ability to influence and align cross-functional teams.
• Proficiency in project management tools and data analytics platforms.
• PMP, PgMP, or similar project management certification preferred.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discounts
• Flexible spending account
• Health insurance
• Life insurance
• Paid Holidays
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance
• Wellness incentives
• UTA Transit Pass