About this role
At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.
The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.
Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
www.terumoaortic.com
Job Summary
Serves as the strategic operating partner to the Site Leader for a single-site Class III medical-device manufacturing operation of approximately 300 employees. Defines and executes short-, mid-, and long-term operational priorities and integrates site strategy across capacity, quality, safety, delivery, cost, workforce planning, and operational excellence through cross-functional influence.
Job Details/Responsibilities
- Develop and maintain the site strategic roadmap and operating plan; translate enterprise and business-unit objectives into site priorities, initiatives, milestones, and measurable outcomes, and support annual and long-range planning cycles.
- Develop mid- and long-term capacity and resource strategies across labor, equipment, facilities, and capital; identify future constraints, capability gaps, investment needs, and required trade-offs in partnership with Finance and functional leaders.
- Establish and sustain an integrated site performance-management and governance process; monitor key indicators for safety, quality, delivery, cost, productivity, and capacity, and provide analyses and recommendations to support executive decisions.
- Serve as a key advisor and member of the site leadership team; help manage leadership cadence, operating reviews, and strategic forums while driving alignment, timely decision-making, cross-functional issue resolution, and accountability.
- Lead site competitiveness, scalability, and transformation initiatives involving efficiency, quality, cost, digitization, automation, and operational excellence; develope business cases, resource plans, milestones, and success measures.
- Partner with Quality and Environmental Health and Safety leaders to integrate quality, safety, regulatory compliance, inspection and audit readiness, and business-continuity considerations into site strategy and operating plans.
- Track execution of the three- to five-year site roadmap, strategic initiatives, and capital priorities; identify risks and dependencies, establish mitigation plans, balance near-term performance with long-term capability, and escalate material issues to site leadership.
Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large
Job Responsibilities (continued)
Working Conditions/Physical Requirements
Knowledge, Skills and Abilities (KSA)
- Strong strategic-planning, business-planning, operational-governance, and site-performance-management capabilities.
- Advanced analytical and financial skills, including the ability to evaluate capacity, resources, capital requirements, performance trends, risks, dependencies, and business trade-offs.
- Demonstrated ability to lead complex cross-functional initiatives and influence decisions without direct authority.
- Strong knowledge of regulated manufacturing operations, preferably Class II or Class III medical-device manufacturing.
- Excellent executive communication, facilitation, presentation, and stakeholder-management skills.
- Ability to develop business cases, define milestones and success measures, prioritize resources, and drive accountability for strategic initiatives.
- Knowledge of capacity modeling, workforce and network planning, capital planning, operational excellence, digitization, automation, and transformation practices.
- Understanding of FDA Quality System Regulation, ISO 13485, and global medical-device regulatory requirements is preferred.
- Lean Six Sigma or an equivalent operational-excellence credential is preferred.
Qualifications/ Background Experiences
- Bachelor’s degree in Engineering, Operations Management, Supply Chain, Business, or a related field.
- At least 10 years of leadership experience in medical-device, pharmaceutical, biotechnology, or another highly regulated manufacturing environment.
- Experience in operations strategy, manufacturing leadership, business planning, operational excellence, project management, or transformation.
- Experience in Class II or Class III medical-device manufacturing.
- Demonstrated experience leading across functions through influence and working with senior site leadership.
- Experience supporting a Site Leader, General Manager, plant leadership team, or equivalent senior operating organization is preferred.
- Experience with capacity modeling, network planning, capital planning, and large-scale transformation is preferred.
An MBA, master’s degree in Engineering, or a related advanced degree is preferred.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.