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Mid-Level Sestems Engineer

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Date: Nov 25, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID: 27942 

 

 

Systems Engineer Level 3

 

JOB SUMMARY

Performs system level engineering work, which requires a broad knowledge of precedents in the specialty area or product line, and a good knowledge of principles and practices of related specialties or product lines.  Duties assigned require experience and familiarization with engineering methods, independent thinking, and company practices and policies.

 

ESSENTIAL DUTIES

  • Performs independent evaluation, selection, and application in making adaptations and modifications to medical device or laboratory products.
  • Receives assigned project leadership responsibilities on a portion of major projects, and  total management responsibility for smaller projects.
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Implements and understands FDA and other regulatory requirements as necessary.
  • Supports internal and external audits of medical device products.
  • Provides product and domain specific information required for regulatory submissions.
  • Owns product level documents, manages and implements Design Control documentation according to appropriate QMS requirements.
  • Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
  • Highlights risks, and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                  
  • Advises team members pro-actively on technical ideas and promotes skill development of team work.
  • Interacts with peers across projects to secure resources and commitments.
  • Handles frequent inter-organizational and outside customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with specific projects.
  • Follows technical specification requirements and provides feedback on various technical processes and procedures.
  • Effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.   
  • Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).

 

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 of Science Degree in Engineering, preferred.

 

Experience

  • Minimum 4 years experience.
  • Product Development experience
  • Medical Device Experience
  • Systems Engineering: In-depth understand of how hardware, software, and disposables interact in a systematic way
  • Customer Interaction

 

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
  • Strong interactive skills in general communication, 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.
  • Strong technical problem solving skills.
  • Understanding of and adherence to GMP practices and FDA regulations.
  • Knowledge and ability to implement FDA and other 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:  $87,800.00 to $109,800.00  -  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. 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.


Nearest Major Market: Denver

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