Director, Global Systems Engineering - E6

Requisition ID:  31821  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

JOB TITLE: Director, Global Systems Engineering

 

JOB SUMMARY

The Director, Global Systems Engineering leads the systems engineering team that develops and supports TBCT’s  (Terumo’s Blood and Cell Therapy) products and solutions within the medical device industry.  This leadership role leverages systems engineering expertise, customer focus and people leadership  to launch new products and supports existing lines with a view to ensuring integration and alignment between key disciplines (i.e. mechanical, electrical, software, etc.).  The incumbent is responsible for new product development and sustaining engineering teams (devices & disposables) and ensures nimble and effective resource allocation across projects and initiatives.

 

ESSENTIAL DUTIES

• Leverage diversity and breadth of experience to embed a “Systems Mindset” into design and development for usability, serviceability, reliability and manufacturability across the product portfolio and the duration of the product life cycle and throughout R&D globally
• Understands and ensures successful development and execution of design controls including: user needs, product requirements, regulatory submission support, verification/validation (testing, writing protocols, risk mgmt., reporting, documentation & tracing across domains)
• Utilizes technical experience, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to projects and products used globally oversight for the development of specification requirements, technical procedures and processes across multiple disciplines to positively impact project success
• Displays a deep understanding of products and issues vital to the company, working with multiple functions across the organization
• Participates in the short and long term planning process to establish technical objectives for the business unit and/or functional engineering group
• Completes regular resourcing and budgeting analyses pertaining to the team
• Implements and understands FDA, CE and other global regulatory body requirements as necessary, in partnership with cross-functional colleagues.
• Ensures compliance with company Quality System regulations and safe working practices
• Assess, manage and mitigate risks associated with project execution across the product portfolio
• Actively mentors, develops and provides leadership to all levels of engineering staff
• Solicits ideas of others and actively contributes to a company-wide environment conducive to inspiration, learning and engagement

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

• Bachelor of Science, engineering degree required
• Master of Science and/or Business degree preferred

 

Experience

• Minimum 10 years developing medical devices, required
• Minimum 8 years of systems design, medical device and/or leading engineering teams, preferred

 

Skills

• Capacity to define and communicate engineering challenges and provide guidance to top management in developing and implementing positive and proactive solutions
• Effectively listens to, solicits input from and engages with customers to understand and integrate their needs, ideas and environment

• Knowledge of business and leadership principles involved in strategic planning, tactical execution, resource allocation, production methods, and coordination of people and resources
• Knowledge of applicable government and regulatory environment

 

LEADERSHIP PROFILE / EXPECTATIONS & COMPETENCIES

• Strategic Mindset / Global Perspective- thinks strategically and broadly with varied viewpoints to effectively implement plans.  Thinks critically and is a creative problem solver for the short and long-term challenges.
• Business Acumen / Customer Focus – understands the market, in