Sr Mgr R&D Global Engineering Operations

$198,500 - $198,500/Yr

Terumo BCT - Lakewood, CO

Full-time - Senior

Lakewood, CO

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Sr. Manager - R&D Global Product Engineering Operations at Terumo Blood and Cell Technologies is a pivotal role responsible for the strategic expansion and optimization of the company's Global Product Engineering capabilities. This position ensures the efficient management of R&D centers globally, aligning product engineering operations with business objectives, driving innovation, and maintaining high standards of quality and compliance in the highly regulated medical device industry. The role involves leading cross-functional teams and overseeing complex multi-site projects to enhance operational efficiency, accelerate product development, and ultimately improve product performance on a global scale. In this role, the Sr. Manager will manage and provide leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes while supporting overall business and corporate objectives. The position requires driving system engineering principles through robust engineering process adherence within the team and cross-functional counterparts. Building strong connections with functional counterparts is essential to identify issues early and drive solutions that consider the whole system. The Sr. Manager will participate in both short and long-term planning processes that establish technical objectives for business unit projects or functional engineering groups. Utilizing technical and managerial expertise, the manager will evaluate proposed solutions, adaptations, and modifications to processes, projects, and products used globally. The role also involves driving engineering excellence in product design transfer to manufacturing, procedure, and service, identifying project and product opportunities, and initiating prioritization in addition to implementation. The manager will be accountable for annual department budgeting and long-range planning, ensuring compliance with FDA and global regulatory requirements, and maintaining adherence to company Quality System regulations and safe working practices.

Responsibilities

• Manage and provide leadership for the functional group's development, direction, and effectiveness.
• Drive system engineering principles through robust engineering process adherence within the team and cross-functional counterparts.
• Build strong connections with functional counterparts to identify issues early and drive solutions.
• Participate in the short and long term planning process that establishes technical objectives for a business unit project or functional engineering group.
• Utilize technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to processes, projects, and products used globally.
• Drive engineering excellence in product design transfer to manufacturing, procedure, and service.
• Identify project and product opportunities and initiate prioritization in addition to implementation.
• Complete annual department budgeting and be accountable for long range planning.
• Implement and understand FDA and global regulatory requirements as necessary.
• Ensure compliance with company Quality System regulations and safe working practices.

Requirements

• Bachelor's of Science in engineering field required.
• Six Sigma Green Belt or Black Belt required.
• Minimum 10 years experience in relevant fields.
• Successful execution in engineering process development such as requirements/specification development, risk management, verification and validation, or other systems engineering processes.
• Experience in both systems engineering and software engineering.
• Design and process analysis using FMEAs.
• Technical investigations and CAPA experience.
• Experience with regulatory inspections.
• Manufacturing and supplier specification development experience.
• Proficiency in statistical tools - Statistical Process Control, Sampling, Design of Experiment.
• Project execution in a cross-functional/cross-cultural environment.

Nice-to-haves

• Exceptional engineering skills and strong commitment to a rigorous process approach to engineering.
• Demonstrated ability to lead a multi-discipline engineering and scientific team both as a direct leader and via influencing.
• Ability to work across culture boundaries, particularly in India, China, Japan, and Latin America.
• Skilled ability to balance commercial and development needs to accomplish global business area goals.
• Advanced understanding and application of Engineering Processes and Quality Management System applied to product development, transfer, and manufacturing.
• Effective leadership, managerial, and strategic planning skills.

Benefits

• Multiple group medical, dental and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance.
• 401(k) plan with a matching contribution.
• Vacation and sick time programs for associates.