Share this Job

Director Process Engineering

Date: Jan 1, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22683  

 

JOB SUMMARY

Directs the activities of the Disposable Manufacturing Engineering and Process Development teams across multiple manufacturing sites to achieve the company’s business objectives.  Provides technical leadership and ensures sound engineering procedures and effective use of facilities. Ensures engineering activities are in accordance with organizational standards.  Responsibilities include strategy development as it relates to regional/global process engineering, tactical execution of manufacturing operations and timelines, streamlining processes, fostering innovation and creative solutions that meet both internal and external customer needs, while ensuring the quality and safety of our products. 

 

ESSENTIAL DUTIES

  • Participates in the short- and long-term strategic planning process that establishes technical objectives for a business unit project portfolio or functional engineering group.
  • Responsible for creating and tracking the budget including project cost estimation, staffing, and timelines. 
  • Communicates on all levels with senior executives and management, including technical, strategic, and business.
  • Identifies project and new process opportunities and is able to articulate value and risk of opportunities. 
  • Ensures process and equipment design and documentation meets FDA and global regulatory requirements.
  • Identifies gaps and develops best practices and process improvements for project execution or functional area.
  • 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 Process Development and Operations senior leader’s vision of transparency, collaboration, and engagement. 
  • 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
  • Align and manage project portfolio to deliver the company strategic plan.
  • Plans and implements new processes for existing products. 
  • Assesses manufacturability and cost effectiveness of current manufacturing processes with goal of year-on-year productivity improvement. 
  • Provides input to, or determines, make/buy decisions based on quality, schedule and cost, as well as provides alternative manufacturing or design options that ensure intended performance, quality, schedule and cost requirements. 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Knowledge and experience typically gained through a Bachelor’s degree (engineering or related discipline), preferably an advanced degree.

 

Experience

  • Minimum 15 years of progressive experience, 10 of which have been in a management capacity.
  • Requires experience with program and project management methods and tools.
  • Must demonstrate the following competencies:
    • Command the respect of the technology team with engineering proficiency,
    • Documented involvement in process excellence,
    • Disciplined execution, drive for results and meeting agreed upon deadlines,
  • Partnership experience with cross disciplinary teams
  • Ability to work within international teams, building relationships and results through consultative and constructive leadership.
  • Direct experience working in regulated environment with regulatory agencies and evolving regulatory issues.
  • Desired medical device industry or equivalently regulated industry experience. 

 

Skills

  • Ability to solve practical problems and interpret and communicate complex engineering requirements in a manner that allows maximum product flexibility without compromising quality standard.
  • Capacity to define and communicate engineering challenges and provide guidance to top management in developing and implementing positive and proactive solutions. 
  • Demonstrated ability to interact productively and to influence peers, external colleagues and senior management.
  • Must have an expert theoretical knowledge of the Engineering functions in all primary disciplines, including in-depth practical knowledge of how to apply these principles.
  • Knowledge of current FDA regulatory and ISO requirements and trends affecting medical devices.
  • Extensive knowledge of process equipment support, improvement and implementation
  • Demonstrated leadership experience with complex machinery, manufacturing processes and associated support teams
  • Must be detail oriented, well organized and able to work independently and in teams.
  • Demonstrated ability to communicate effectively both verbally and in writing Demonstrated ability to lead people to get results through others with strong interpersonal / conflict resolution skills.
  • Possess a strong commitment to company values.
  • Demonstrated knowledge of manufacturing operations, process validation, engineering, tactical execution, customer service, professional communications, cross functionality, computer applications, problem solving, strategic reasoning, teamwork, change management, business acumen and business ethics.

     

Certificates, Licenses, Registrations

  • Must possess a valid passport.

 

ADDITIONAL INFORMATION

There will be an occasional requirement to work outside of normal business hours, consisted with other Director-level positions.

~ 25% US and International travel will be required in support of multiple, manufacturing sites.

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

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: Process Engineer, Manager, Engineer, R&D Engineer, Medical Device Engineer, Engineering, Management