Manager, Systems Engineering - Specialist (E4)

Requisition ID: 33435

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. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

Manager, Systems Engineering - Specialist (Engineer 4)

JOB SUMMARY

Manager of Systems Engineering leads the organization in innovative systems approaches to both technical solutions and product develop processes. Duties include assigning work and mentoring direct reporting System Engineers (Lead System Engineers / Lead System Designers) in their Systems Engineering tasks, including design and development, verification and validation testing, and investigations/root cause determinations. Responsible for the development of solutions to problems of high complexity and broad company implications.

ESSENTIAL DUTIES

• Manages and provides leadership and mentorship for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Subject Matter Expert to guide projects and mentor other System Engineers on at least one of the following:
  
  
  
  • Testing methodologies for verification and validation, product changes, and investigations
  • Verification and integration strategy
  
  
  
  
• Drives system engineering principles through robust engineering processes within team and cross-functional counterparts.
• Builds strong connections with functional counterparts to identify issues early and drive solutions with our optimal considering the whole system.
• Participates in the short- and long-term planning process that establishes technical objectives for a business unit project or functional engineering group.
• Utilizes technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to processes, projects, and products used globally.
• Drives engineering excellence in produce design transfer to manufacturing, procedure, and service.
• Identifies project, product opportunities and initiates prioritization in addition to implementation.
• Completes annual department budgeting and accountable for long range planning.
• Implements and understands FDA and global regulatory requirements as necessary.
• Ensures compliance with company Quality System regulations and safe working practices.
• Demonstrates broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.
• Uses systems thinking to design complex platforms integrating equipment, software, and disposables, achieving functional and reliability goals.
• Define integration and verification plans, defining adequate resources and time for execution of the plans.

OTHER DUTIES AND RESPONSIBILITIES

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Performs other tasks at managers request to ensure the success of project and the overall business.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 8 years experience, 3 years managing others.

• Minimum 5 years experience in at least one of the following:
  
  
  
  • Testing methodologies for verification and validation, product changes, and investigations
  • Planning and executing strategy for verification and integration.
  
  
  
  

• Successful execution in most if not all of the following areas:
  
  
  
  • Engineering process development such as requirements/specification development, risk management, verification and validation or other systems engineering processes.
  • Experience in both systems engineering and software engineering.
  • Technical investigations and CAPA.
  • Regulatory inspections.
  • Manufacturing and supplier specification development.
  • Statistical tools - Statistical Process Control, Sampling, Design of Experiment.
  
  
  
  

Skills

• Change leader who identifies opportunities and then designs and implements solution to capitalize on those opportunities.
• Exceptional engineering skills and strong commitment to a rigorous process approach to engineering.
• Demonstrated ability to lead a multi-discipline engineering and scientific team both as a direct leader and via influencing.
• Skilled ability to balance commercial and development needs to accomplish global business area goals.
• Advanced understanding and application of Engineering Processes and Quality Management System applied to product development, transfer, and manufacturing.
• Broad knowledge of engineering, management, quality, global regulatory standards, and/or manufacturing.
• Ability to quickly gain working knowledge of the business's products and therapeutic uses.
• Effective leadership, managerial, and strategic planning skills.
• Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.

Target Pay Range:$123,600.00to$154,500.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:10.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  
  
  
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
  
  
  
  
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.