Process Engineering Director jobs in Colorado

Director, Process Improvement Engineering

• Participates in the short- and long-term strategic planning process that establishes technical objectives for a functional process 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.
• Ensures compliance with Terumo BCT Quality System regulations and safe working practices.
• Utilizes technical skills to evaluate proposed design, adaptations, and modifications to manufacturing processes.
• 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 applicable procedures.
• Responsible for the review, evaluation, and development of the engineering team within a cross-functional environment.
• 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.
• Works closely with other senior level people within and outside of the company to resolve highly complex and sensitive issues.
• Delegates work assignments matching responsibility to the person and gives authority to work independently. Sets expectations and monitors delegated activities.

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

• 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 have the important leadership traits. This includes demonstrating the following competencies:
  • Command the respect of the technology team with engineering proficiency,
  • History of developing both technology and people leadership underneath,
  • Documented involvement in process excellence,
  • Disciplined execution and drive for results and meet agreed upon deadlines,
  • History of success with building products that meet customer needs and quality standards required in a regulated industry,
  • Partnership credentials with cross disciplinary teams such as product management, marketing management, manufacturing, services, sales, IT, legal, clinical, regulatory affairs and quality, project management, HR functions, and other functions within an organization.
• Ability to maneuver through international teams, and building relationships and results through consultative and constructive leadership abilities are a must. The leader must exhibit a “player-coach” trait, of being very involved in day to day detail management with simultaneous trait for thinking long term strategy.
• Direct experience working in regulated environment with regulatory agencies and evolving regulatory issues.
• Desired medical device industry or equivalently regulated industry experience.

• 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
• Ability to help management team balance engineering requirements with business requirements and identify solutions to meet both sets of requirements.
• 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.
• Effectively deliver results in a matrixed organization.

• 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.

Nearest Major Market: Denver
Job Segment: Business Process, Medical Device, Medical Device Engineer, Process Engineer, Behavioral Health, Management, Healthcare, Engineering