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Engineer 5 - Engineering Center of Excellence

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Date: Sep 17, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27959  

 

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. 

Engineer Level 5 – Engineering COE (Center of Excellence)

 

 

JOB SUMMARY

This role provides strategy, thought leadership and direction on projects and initiatives focused on Enabling Development Technology, Quality and Regulatory across all areas of the I&D (Innovation and Development) Engineering organization.  Serves as primary cross-functional interface with Quality and Regulatory organizations and works across all areas within  I&D to ensure alignment to COE strategy and objectives.

 

ESSENTIAL DUTIES

  • Develops, implements and communicates protocol, systems and processes to ensure Quality and Regulatory objectives are understood and achieved within I&D and cross-functionally
  • Serve as subject matter expert within I&D to help development teams with standardized application of product development tools in the ongoing development of legacy and new products
  • Leads and provides coaching, technical oversight and direction to COE team
  • Serves as I&D champion on all Quality and Regulatory related goals and initiatives
  • Assures tools are developed and implemented for efficient development of new products globally
  • Establish and train best practices globally and build strategy to update and manage product DHFs (Design History Files)
  • Aligns EUMDR submission needs strategically with existing artifacts and satisfies new data requirements that support future product development / sustaining needs
  • Collaborates with I&D and Regulatory resources to establish standards for minimum viable requirements for regulatory submissions
  • Lead the development of standardized systems that automate data capture and analysis in a global/searchable database for development of future products
  • Supports product evaluation / compliance evaluation to changing regulations and standards
  • Establish standardize method to incorporate international and regional standards into product requirements / DHF’s for efficient development and sustaining support
  • Recommends the global organization and linkage of DHF artifacts and supporting data

 

OTHER DUTIES AND RESPONSIBILITIES

  • Establish standardized methods for verification to product requirements and outgoing quality expectations at launch
  • Collaborates and ensures alignment with key leaders and stakeholders cross-functionally and within I&D
  • Anticipates problems, generates technically advanced alternatives and implements innovative solutions for complex problems which require the regular use of ingenuity and creativity
  • Understands the impact process change in one area will have on other areas and manages the impact of changes
  • Identifies risks and understands how to approach and complete multiple tasks/projects, avoiding major delays in schedules and product introduction or eventual loss of business 
  • 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 of Science degree or Master of Science degree in Engineering preferred
     

Experience

  • Minimum 15 years’ experience
  • Two years of GMP manufacturing experience required

 

Skills

  • Demonstrated ability to interact productively and to effectively influence peers and external colleague and senior management
  • Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices
  • Experienced with design control methodologies
  • Experience with developing medical products in regulated industry
  • Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology

 

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:  $130,700.00 to $163,400.00  -  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:  20.0%

 

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. 


Nearest Major Market: Denver

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