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Engineer 5 - Sustaining Integration Lead

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Date: Nov 27, 2020

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  26201  

 

 

<span style="font-family:"Calibri",sans-serif">Plans and directs major engineering projects of a complex nature.  Applies intensive and diversified knowledge of engineering principles and practices in broad areas of assignments.  Plans, schedules, and coordinates detailed phases of the engineering work in a part of a major project or in a total project. 

  

ESSENTIAL DUTIES

Systems Integration Engineer:

  • Ability to perform and manage the performance of hardware integration, test planning and execution
  • Use of Design Controls per FDA regulations and EU MDR requirements with Class I, II and III devices.
  • Use of Design of Manufacturing activities.
  • Establish Cost Reduction activities during sustaining engineering efforts.
  • Ability to perform and manage the application of PDM and PLM systems.
  • Support device regulatory requirements with outside regulatory bodies (CSA, UL, InterTek, etc.)
  • Identify engineering risks and opportunities, manage into the process and harvest the benefits
  • Hold sustaining project request owners accountable for assessment of project impact and high-level cost assessments and serve as neutral "arbiter" to ensure fairness of assessments
  • Schedule, lead and own follow-ups from sustaining leadership and operating committee meetings
  • Support and coordinate engineering design reviews and product reviews
  • Develops advanced technological ideas and guides their development into a final product. 
  • <span style="font-family:"Calibri",sans-serif">Understands the engineering impact process change in one area will have on other areas and manages the impact of changes.
  • <span style="font-family:"Calibri",sans-serif">Engages actively with, inspires and drives the effectiveness of teams that integrate multiple functions/disciplines and have broad business impact.   

 

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.
  • <span style="font-family:"Calibri",sans-serif">Bachelor’s of Science degree or Master of Science degree in Engineering preferred.
    <span style="font-family:"Calibri",sans-serif"> 

Experience

  • <span style="font-family:"Calibri",sans-serif">Minimum 15 years experience.
  • <span style="font-family:"Verdana",sans-serif"><span style="font-family:"Calibri",sans-serif">Two years of GMP manufacturing experience required.

 

 Skills

  • Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
  • <span style="font-family:"Calibri",sans-serif">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.
  • <span style="font-family:"Calibri",sans-serif">Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination and prioritization between business units.
  • <span style="font-family:"Calibri",sans-serif">Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
  • <span style="font-family:"Calibri",sans-serif">Regularly and effectively presents complex technical information, analysis, and responds to questions from technical staff members and management.
  • <span style="font-family:"Calibri",sans-serif">Demonstrated ability to communicate effectively both verbally and in writing.
  • <span style="font-family:"Calibri",sans-serif">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.

 

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

Job Segment: Medical, Manufacturing Engineer, Chemical Research, Engineer, Telecom, Healthcare, Engineering, Technology