Systems Engineer Level 2- Plasma Innovations

Requisition ID:  32826  

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: Systems Engineer Level 2- Plasma Innovations

JOB SUMMARY

This engineering role provides front-line troubleshooting support to medical device customers. Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity to help troubleshoot and resolve customer issues. .  Assignments include equipment and software troubleshooting, understanding of specifications, coordination of cross functional teams for issue resolution, customer facing report preparation and other activities of limited scope.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, customer experience and company practices and policies.

ESSENTIAL DUTIES

• Provides customer-facing, frontline device and systems troubleshooting support for medical device customers.
• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
• Analyzes data and presents it in appropriate forums.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.
• Uses data analytics to characterize issues and make recommendations for implementation of new technologies, practices, tools, and equipment to improve customer experience.
• Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
• Tracks and documents customer issues to ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
• Provides work direction to engineering support staff. 
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, indentifying problems, generating alternatives and recommending solutions. 
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members,management and customers.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.

• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.

OTHER DUTIES AND RESPONSIBILITIES

• Work assignments may require additional development and a maturing 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’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 2 years experience.
• Two years of GMP manufacturing experioence highly desired.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• 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 trouble-shooting.
• Interfaces with staff, customers, 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 and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• 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 based on business needs.

Target Pay Range:  $82,000.00 to $102,500.00  -  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:  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.