Engineer 4 - Global Quality Business Excellence (Complaint/Defects Focus)

Requisition ID:  33970  

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.

The Engineer 4 - Business Excellence works in collaboration with Operational Excellence and cross functional business partners to assess, improve and streamline existing quality management system (QMS) processes for the efficient execution of key strategic business initiatives and projects that support customer improvements. Acting as the Quality Engineer driving the business excellence initiatives for global sites, this role delivers sustainable improvements in customer complaint reduction, product quality, management systems and services by participating in or leading improvement projects using continuous improvement methodologies. Creates/delivers customer complaint reduction programs that drive customer satisfaction globally. 

ESSENTIAL DUTIES

• Leads and supports continuous improvement initiatives using PDCA and DMAIC methodologies to enhance product quality, align quality management systems with evolving business needs, and drive strategic initiatives across multiple disciplines.
• Collaborates with cross-functional teams to identify and implement CPM (Complaints per Million) reduction strategies, prioritize actions, and develop execution plans.
• Monitors customer complaint data and trends to enable prompt corrective actions, reduce CPM, and improve global customer satisfaction.
• Applies the E3 framework (Engage, Enable, Empower) to ensure sustainability of improvement initiatives among employees, supervisors, and leadership.
• Leads teams and projects that support the reduction of CPM across our global businesses.  Provides leadership and guidance to cross-functional managers to drive site-specific improvements using structured problem-solving and continuous improvement tools.
• Leads sustainable customer complaint reduction projects grounded in core quality principles, including APQP, control plans, and FMEAs.
• Conducts audits and assessments to evaluate the effectiveness and consistency of implemented improvements across global sites.
• Serves as a trusted advisor on complex technical and industry issues, offering consultation to engineering staff and management.
• Analyzes complex issues requiring in-depth evaluation of variable factors, exercising sound judgment in selecting appropriate methods and criteria.
• Stays current with industry advancements and applies new knowledge to improve products and processes.
• Contributes to the development of business objectives, goals, budgets, and cost strategies as needed.
• Mentors junior engineers, fostering professional growth and technical development.
• Collaborates and ensures alignment with key leaders and stakeholders cross-functionally and within Quality.
• Anticipates problems, generates technically advanced alternatives, and implements innovative solutions for complex problems which require the regular use of ingenuity and creativity.
• Works on significant and unique issues where analysis requires evaluation of intangibles.  Exercises independent judgment in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Engages actively with, inspires, and drives the effectiveness of teams that integrate multiple functions/disciplines and have broad business impact.  
• 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 or eventual loss of business.
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS
Education

• Bachelor's degree in Business Management, Engineering, or other related field of study. Equivalent of eduction and experience sufficient to successfully perform the essential functions of the job may be considered. 
• Bachelor's degree in engineering strongly preferred. 

Experience

• A minimum of 8 years of business operations and/or plant manufacturing or engineering experience, which includes 3 years of demonstrated process improvement program success.
• Two years of GMP manufacturing experience required. Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products preferred.
• Two years of Quality Engineering or Quality Management experience preferred.
• Black Belt LEAN /Six Sigma certification training or comparable, or must be able to complete within first year.
• Professional communication skills and proven leadership capabilities.
• Project management experience and certification preferred.
• Experience with APQP, Control Plan’s, FMEA.
• Experience in development/assessment of automated and manual assembly manufacturing processes.
• Proficiency in Microsoft Team, Excel, Power Point, Minitab (requirements) and Power BI (preferred).

Skills

• Demonstrated ability to interact productively and to effectively influence peers and external colleagues and senior management.
• Skilled in influencing/motivating teams and stakeholders across different sites and cultures.
• Experience with assessing, implementing, and training engineering best practices.
• Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products.
• Coaching and communications skills.
• Ability to identify opportunities where a small change can precipitate transformational changes by teaching and coaching on Lean/Six Sigma principles.
• Strong leadership abilities.

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

TRAVEL
Requires domestic and international travel based on business needs.

PHYSICAL REQUIREMENTS

• General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, traverse, 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 accommodation may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $124,100.00 to $155,100.00  -  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.