Engineer 4 - Supplier Quality

Requisition ID:  30899  

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: Supplier Quality Engineer Level 4

JOB SUMMARY

Supplier Quality Engineering assignments include management of suppliers, projects, and component quality for sterilized, disposable products used in conjunction with Terumo BCT systems. Focus areas are extrusion processes and plastic injection molding.

Responsibilities include management of key suppliers' quality & performance, supplier process validation, process capability and controls, evaluation and implementation of supplier changes, writing technical reports, and other activities of limited scope.

ESSENTIAL DUTIES

• Expertise in the areas of tubing extrusion and plastic injection molding
• Conducts engineering studies and drives decisions for improvement to extrusion equipment, injection molds, measurement systems, and other process equipment to maximize quality of supplied components
• Guides the successful completion of large-scale Continuous Improvement programs and may function in a project leadership role.
• Applies technical expertise and problem-solving methodology to complex issues requiring in-depth evaluation of variable factors.  Leads root cause analysis, corrective and preventive actions.
• Communicates regularly and clearly with suppliers on topics of quality and manufacturing process capability. Develops an environment that facilitates continuous improvement.
• Analyzes data and applies statistical analysis including process capability, equivalence, and measurement system analysis (i.e. Gage R&R). Ability to presents it in appropriate forums.
• Works globally with the engineering and manufacturing teams of multiple factories, as well as other customer-facing stakeholders, to investigate and resolve problems.  Proactively identifies areas of opportunity and drives preventive action.
• Understands specifications, GD&T and appropriate inspection methods for different types of requirements
• Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability
• Mentors less experienced engineers and provides broad-based direction within functional area and cross functionally. 
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results, often influencing the outcome of the team(s)
• Thinks analytically regarding components and subassemblies functioning as a part of larger system

• Follows company and department processes and may develop new business processes that have significant impact

OTHER DUTIES AND RESPONSIBILITIES

• Work assignments may require additional development or broadening of in-depth engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor of Science degree or Master of Science degree
• Preferred education or equivalent experience in the field of mechanical engineering, materials, biomedical engineering, chemical engineering or cellular biology.

Experience

• Minimum 8 years of relevant experience.
• Four years of GMP manufacturing experience in the medical device industry or similar field.

Skills

• Solves problems of diverse scope and complexity
• Ability to apply technology principles to multiple tasks and to generate unique alternatives and solutions
• Continuous improvement mindset, e.g. LEAN, Six Sigma
• Knowledge in statistics and experience with Minitab preferred
• Effective presentation of information and engineering analysis
• Understanding of and adherence to GMP practices and FDA regulations.
• Interactive skills in cross-functional influence, mentoring and acceptance of guidance, partnering with others
• Can work under general direction, independently determining solutions, identifying risks, and avoiding serious delays and or expenditure of time and resources
• Clear communication and coordination with external organizations
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and use of relevant PC software applications and skills to use them effectively. 
• Demonstrated ability to communicate effectively both verbally and in writing.
• Project management

-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

May require up to 15% travel based on business needs.

Target Pay Range:  $117,500.00 to $146,900.00  -  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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.