Manager, Manufacturing Process Development (NPI - Design Transfer)

Requisition ID:  34085  

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.

As the Manager, Manufacturing Process Development (NPI – Design Transfer), you’ll lead a talented team in bringing electro-mechanical medical devices from R&D into full-scale manufacturing. This pivotal, operations-focused role ensures new products are manufacturable, scalable, and compliant with quality and regulatory standards. You’ll collaborate cross-functionally with teams in manufacturing, quality, and regulatory, while mentoring engineers and driving continuous improvement. This is a unique opportunity to shape the future of life-changing technologies in a collaborative and fast-paced environment.

ESSENTIAL DUTIES

• Lead and coordinate design transfer activities from R&D to manufacturing for electromechanical systems.
• Manages and provides leadership for the group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for ongoing partnership and alignment with peers in key areas such as, but not limited to, manufacturing, R&D, marketing, quality assurance, and regulatory affairs.
• Responsible for the project and or work group expenditures vs. plan.
• Implements and understands FDA and other regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Plans, guides, and reviews projects and/or work groups under one’s control to produce the desired outcome.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Frequently presents project updates, including budget status, technical risks, and accomplishments to upper management.
• Responsible for monitoring and providing timely and regular feedback on job performance of direct reports.
• Expected to provide detailed, technical mentorship and technical decision-making support for engineering team.
• Identifies and drives continuous improvement projects for process improvement.

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 10 years experience.
• Experience managing multiple direct reports desired.
• Medical device experience highly desired.
• Design transfer experience desired.

Skills

• Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as a primary technical contact on project issues and decisions. Interacts with senior level associates on significant technical matters often requiring coordination between teams.
• Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
• Driver for acquiring resources and building consensus across products.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Regularly and effectively presents complex technical information/analysis and responds to questions from technical staff members and management.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

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

LOCATION
Lakewood, Colorado - Onsite - Open to candidate willing to relocate to the area. 

TRAVEL
May require domestic or international travel based on business needs. Likely less than 10%.

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.

Target Pay Range:  $122,100.00 to $152,600.00  -  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.