- 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.
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Director, Process Improvement Engineering - Littleton, United States - Terumo BCT
Description
Requisition ID: 32032At 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.
Directs the activities of the Process Improvement Team across global manufacturing sites to achieve the company's quality improvement objectives. This role works very closely with Global Quality and Global R&D to drive and achieve improved outcomes. Provides technical leadership and ensures sound engineering procedures and effective use of improvement tools and methodologies. Responsibilities include strategy development, tactical response and leadership of acute quality issues, improvement and execution of manufacturing 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
Education
~ 25% US and International travel will be required in support of multiple, manufacturing sites.
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.
PHYSICAL REQUIREMENTS
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.
Target Pay Range: $180,200.00 to $225, 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 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.
