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Dir Product Development Engineering COE

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Date: May 6, 2022

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  29135  

 

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. 

Director, Engineering Services & Training

 

JOB SUMMARY

 

The Director leads the team responsible for Engineering Services and Training within the I&D (Innovation & Development) organization.  This function provides technical and operational thought leadership, ensures operational excellence and establishes best practices across the I&D organization  including Equipment, Disposables, New Product Development, Systems, Sustaining Engineering, Software and Scientific/Clinical Affairs.   This role will also have leadership oversight for facilitating cross-organizational operational excellence – i.e. Regulatory Affairs, Operations and Quality.

 

This leadership role will improve product development and engineering quality and efficiency by providing tertiary technical support across projects, establishing consistent engineering and operational practices and policies across I&D globally.  Additionally, the COE Director provides strategic leadership for the development of engineers,  engineering tools, and ensures sound engineering procedures and effective use of global laboratory facilities in accordance with organizational and regulatory standards.  Responsibilities include strategic focus on execution of engineering principals fostering innovation and creative solutions that meet both internal and external customer needs, while ensuring the quality and safety of our products. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  • Establish and implement standardized best practices for the development of new products, processes, product/design modeling, tools and technologies i.e. Windchill, CAD, Integrity, Relics, etc.
  • Acts as an internal champion for quality initiatives aimed at improving business systems and compliance
  • Establish global world-class development laboratories by assessing and implementing consistent standards, test methods, test equipment and data management that aligns and evolves with technological advancement, project and business needs
  • Understand and ensure organizational alignment to changes in regulatory environment – i.e. Non-DEHP, CMR, EUMDR, International Standards
  • Reduce delivery times, development, and maintenance costs by increasing efficiencies and leveraging reusable assets
  • Assess engineering and product development skills/capabilities, identify and implement training and development aligned to evolving and emerging technical landscape
  • Identify project and new product opportunities and articulate value and risk of opportunities across the global I&D organization
  • Ensure compliance with FDA, global regulatory requirements, TerumoBCT Quality System regulations and safe working practices
  • Ensure alignment and cross functional communication with product development, sustaining, and process development teams
  • Attract and develop team of subject matter and technical experts who consult and collaborate within I&D and cross-functionally

OTHER DUTIES AND RESPONSIBILITIES

  • Leverage experience and technical expertise to evaluate proposed design, adaptations, and modifications to projects
  • Provide critical input into the development of product strategy and research and development of new and emerging technologies
  • Coordinate with representatives from the Quality organization to identify requirements and ensure compliance with Design Control procedures
  • Champions and supports effective change management initiatives and drives culture, leading through influence and alignment to the Product Development senior leader’s vision of transparency, collaboration, and engagement

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • B. S. degree in Engineering required
  • M.S. or PhD degree in Engineering combined with management degree preferred

Experience

  • Minimum 15 years of progressive experience in a technical field (medical devices, bio medical, etc.) -  10 of which have been in a management capacity
  • Demonstrated ability to lead a multi-discipline engineering team working on multiple projects in a matrixed environment
  • Expert level understanding and application of Design Controls, Quality Management System to product development to solve problems and interpret and communicate complex engineering requirements
  • Experience in a Regulated Environment is required, examples include but are not limited to: FDA, MDSAP, and EU Notified Bodies

COMPETENCIES AND SKILLS

  • Ensures Accountability - Takes accountability for self – and holds others accountable – to keep commitments, focus to the finish, and achieve results
  • Leads Change - Navigates uncertainty and leads others through change by creating vision and executing strategy with discipline, alignment, and ongoing communication
  • Strategic Mindset / Global Perspective- Exercises strategic, critical and global thinking with a customer and market focus
  • Collaborates – Builds partnerships cross-functionally and works collaboratively with others to meet shared objectives
  • Instills Trust - Unquestionable integrity, ethics and character. A role model for the Terumo Core Values

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

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.

 

Requires travel based on business needs

 

Target Pay Range:  $168,900.00 to $211,100.00  -  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:  30.0%

 

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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