Engineer 4 - Continuous Improvement - Factory Level

Requisition ID:  32325  

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.

This position will plan and directs major projects of a complex nature for continues improvement. Applies intensive and diversified knowledge of engineering principles, statistics, quality tools  and best practices in broad areas of assignments. Plans, schedules, and coordinates detailed phases of the work in a part of a major project or in a total project. 

This role, based at Terumo Blood & Cell Technologies (TBCT) Littleton, CO, factory will have a significant impact as the primary quality engineer driving improvement activities that will support a number of strategic factory objectives. The Littleton factory currently supports all disposable manufacturing for TBCT’s Plasma Innovations business. This factory has a highly automated manufacturing process for disposable medical devices and this quality engineer will be a part of a variety of improvement initiatives to drive more efficient and effective manufacturing as this facility continues to ramp-up production over the next few years. This role presents an unique opportunity as part of the quality leadership team that is supporting the highest growth factory in the TBCT global network.

ESSENTIAL DUTIES

• Lead the project to implement statistical process control at the Littleton to find and eliminate defects that generate NCs, customer complaints, and/or operational inefficiencies.
• Use data and trending to identify, prioritize, and drive projects to reduce the incidence and impact of  quality issues with the goal of complaint reduction and process improvement.
• Lead and co-drive trending activities cross-functionally.
• Provides significant input into technical strategy, acting as a subject matter expert and broader support to other cross-functional teams.
• Proactively anticipates manufacturing issues, and process variations, generates and evaluates technical solutions,  and implements solutions for complex problems.
• Lead or support root cause investigation and problem solving execution and effectiveness, using quality tools to address recurrent issues. 
• Understands the impact process change in one area will have on other areas and manages the impact of changes.
• Identifies risks and understands how to approach and complete multiple tasks/projects, avoiding major delays in schedules and product introduction, major impact emerging issues or eventual loss of business. 
• Serves as organization spokesperson on advanced projects and/or programs.
• Writes technical procedures, engineering reports, or other quality documents on various processes that impact multiple disciplines and provide a compliance framework.
• Champions and sponsors own ideas of others within and across products, functions and businesses, and significantly influences team direction and incorporation of innovative member ideas.
• Engages actively with and works effectively with teams that integrate multiple functions/disciplines and have broad business impact. Make sure trending is in here.

• Work direction responsibility may include technicians and engineers.

• May work with manufacturing and other functional groups on manufacturing, quality and compliance issues.

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.
• Comfortable with use of various statistical methodologies  preferred.
• Six Sigma Black Belt Certification is preferred.

Experience

• Minimum 8 years experience.
• Five years of medical device or pharmaceurtical manufacturing  experience required.
• Two years of GMP manufacturing experience, preferably in Quality.

Skills

• Demonstrated skills in statistics, data analysis, root cause analysis, DMAIC and quality tools.
• Enjoys and is effective at using a high level of ingenuity and creativity for problem-solving.
• Ability to navigate ambiguity and provide options, solutions, and paths forward to solve issues.
• Demonstrated skills inchampioning a growth mindset and continuous improvement mentality, influencing and coordinating cross functional team members, mentoring of junior engineers and technicians,, and providing technical leadership and project management.
• Represents the organization as the prime technical contact on quality improvement projects. Interacts with various levels of personnel on significant technical matters, often requiring coordination between internal groups
• Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
• Comfortable with regularly and effectively presenting complex technical information and analysis, and responding to questions from technical staff members and management.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant stastical process control applications, such as Infinity QS preferred, along with demonstrated skills in using such software effectively.

-Or-

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

LOCATION

Littleton, Colorado - Open to candidates willing to relocate to the area. 

TRAVEL

Requires travel based on business needs, maximum will be 20%.

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:  $123,600.00 to $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.