Manager, Manufacturing Process Development (NPI - Design Transfer)

Requisition ID:  34085  

 

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. For Terumo, for Everyone, Everywhere.

 

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. Advancing healthcare with heart.

 

 

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. Join us and help shape wherever we go next. You create your future and ours.

 

As the Manager, Manufacturing Process Development (NPI – Design Transfer), you’ll lead a talented team in bringing electro-mechanical medical devices from R&D into full-scale manufacturing. This pivotal, operations-focused role ensures new products are manufacturable, scalable, and compliant with quality and regulatory standards. You’ll collaborate cross-functionally with teams in manufacturing, quality, and regulatory, while mentoring engineers and driving continuous improvement. This is a unique opportunity to shape the future of life-changing technologies in a collaborative and fast-paced environment.

ESSENTIAL DUTIES

• Lead and coordinate design transfer activities from R&D to manufacturing for electromechanical systems.
• Manages and provides leadership for the group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for ongoing partnership and alignment with peers in key areas such as, but not limited to, manufacturing, R&D, marketing, quality assurance, and regulatory affairs.
• Responsible for the project and or work group expenditures vs. plan.
• Implements and understands FDA and other regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Plans, guides, and reviews projects and/or work groups under one’s control to produce the desired outcome.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Frequently presents project updates, including budget status, technical risks, and accomplishments to upper management.
• Responsible for monitoring and providing timely and regular feedback on job performance of direct reports.
• Expected to provide detailed, technical mentorship and technical decision-making support for engineering team.
• Identifies and drives continuous improvement projects for process improvement.

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

 

Experience

• Minimum 10 years experience.
• Experience managing multiple direct reports desired.
• Medical device experience highly desired.
• Design transfer experience desired.

 

Skills

• Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as a primary technical contact on project issues and decisions. Interacts with senior level associates on significant technical matters often requiring coordination between teams.
• Follows and develo