Global Manufacturing Engineer 3

Requisition ID:  31292  

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. 

As a Manufacturing Engineer where you'll play a pivotal role in supporting the seamless transfer of products across our global manufacturing locations. You'll have the opportunity to make a real impact by driving process improvements to address challenges identified through feedback channels, and you'll lead projects ranging from smaller initiatives to major endeavors. You'll thrive on dissecting complex issues, devising ingenious solutions, and ensuring projects stay on track. Your expertise in mechanical engineering will shine as you collaborate within cross-functional teams, offer technical guidance, and uphold regulatory compliance. If you're a skilled bilingual communicator, possess a Bachelor's or Master's in Mechanical Engineering, have experience in GMP manufacturing, and excel in technical leadership, this role offers a platform to grow, innovate, and shape the future of our products on a global scale.

ESSENTIAL DUTIES

• Supports transfer of products between global manufacturing locations.
• Makes changes/improvements to existing processes to resolve issues identified through complaints, manufacturing or other feedback mechanisms.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects. This includes development of project scope and estimates, management of costs to budget, and support of final documentation in accordance with acceptable engineering practices.
• Takes initiative and demonstrates inquisitive approaches to solve complex problems, identifying problems, generating alternatives and recommending solutions. 
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                  
• Prepares and reviews engineering/technical documents such as reports, protocols, schedules and budgets, and vendor-provided documents and drawings.
• Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools and equipment.
• Analyzes data and presents it in appropriate forums.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Advises team members proactively on technical ideas and promotes skill development of teamwork.
• Provides work direction to engineering support staff. 
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent interorganizational and outside customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Ensures that processes and equipment designs are compliant with all company policies and procedures, as well as all International, Local, State, and Federal directives, laws and regulations.
• Follows department processes and regularly makes recommendations on these processes.
• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.

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.

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’s of Science degree or Master of Science degree in Mechanical Engineering preferred.

Experience

• Minimum 4 years experience.
• Two years of GMP manufacturing experience preferred.

Skills

• Bilingual in English and Mandarin with demonstrated ability to communicate effectively both verbally and in writing preferred.
• Requires demonstrated skills in technical innovation, technical leadership, mechanical engineering.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Mechanical and electronic ability and aptitude to assist with equipment troubleshooting.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices, FDA regulations and international standards.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Experience with Tolerance Analysis, as well as reading and applying principles of GD&T
• Experience with multiple manufacturing techniques (Machining, Sheet Metal, Plastic Injection Molding, Casting, etc.)
• Experience in PLM/PDM system. (Windchill Preferred)

-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 based on business needs, including internationally.

Target Pay Range:  $99,200.00 to $124,000.00  -  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:  7.0%

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.