Manufacturing Process Improvement Engineer 4

Requisition ID:  33174  

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.

JOB TITLE: Manufacturing Process Improvement Engineer Level 4

JOB SUMMARY

Performs duties that require application of intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.  Develops and evaluates plans and criteria for a variety of projects and activities.  Carries out complex or novel research assignments requiring the development of new or improved techniques and procedures. 

ESSENTIAL DUTIES

• Responsible for evaluation and improvement in medical devices manufacturing processes.
• Deliver robust products and production processes based on Quality by Design and risk-based approach and efficiently apply data analysis methodology to support critical decision making.
• Employ appropriate techniques/methods to successfully and independently complete routine assignments within negotiated deadlines. Identify existing alternative methods and innovative technologies for improving existing or new products/processes.
• Develop appropriate study design, complete the study and write appropriate documentation to support development, improvement and manufacturing studies.
• Conduct studies to support manufacturing process improvement or to provide technical justifications for changes control.
• Accurately assess results for validity and conformance to process/product specifications.
• Maintain current knowledge of relevant regulatory requirements related to R&D (product development, process validation, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Independently conduct failure analysis, making conclusions and recommend solutions to complex problems.
• Leads and is accountable for projects and drives results.
• Guides the successful completion of major programs and may function in a project leadership role.
• Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
• Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.
• Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.  
• Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
• Ensures compliance with Terumo BCT Quality System regulations and safe working practices.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the establishment of business objectives, goals, budgets and costs.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Minimum B.S. Degree in Mechanical, Manufacturing, BioMedical or related field.

Experience

• 15 years of demonstrated experience of Manufacturing/Process Engineering in GMP manufacturing environment.  

Skills

• Strong knowledge on medical device manufacturing processes such as: assembly, material joining, extrusion and injection molding.
• Knowledge with regulations, policies, global pharmacopoeia, procedures such as EMEA, GDP, GMP, FDA guidelines, ISO standards, and ASTM standards.
• Demonstrated 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 the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
• Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• 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.

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: 30%

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.