Manager, Product Lifecycle Engineering

Terumo BCT, Inc. • Denver, CO

23h • $129,300 - $161,600 • Hybrid

About The Position

As the Manager, Product Lifecycle Engineering, you will play a key leadership role in advancing our medical device portfolio by optimizing product lifecycle processes and enabling the delivery of high-quality, patient-focused solutions. As part of the Product Lifecycle Excellence Team, you'll leverage your expertise in Windchill and engineering best practices to lead complex initiatives, solve challenging technical problems, and implement process improvements that support the entire product lifecycle. Reporting into Quality, you will collaborate with cross-functional teams to shape the future of life-saving technologies while influencing strategic projects with global impact. This is an exceptional opportunity for an innovative leader who thrives in a dynamic environment and is excited to make meaningful contributions to the next generation of medical devices.

Requirements

• Bachelor’s degree in engineering or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Minimum 8 years experience.
• Two years of GMP manufacturing experience required.
• Extensive experience in utilizing Windchill PLM software for product lifecycle management, including version control, change management, and document control.
• Strong understanding of regulatory requirements specific to the medical device industry (e.g., FDA regulations, ISO standards), ensuring all documentation and processes adhere to these stringent guidelines.
• Proven ability to manage and optimize product data throughout its lifecycle, from conception through design, manufacturing, service, and disposal.
• Knowledge and use of relevant PC software applications, with skills to use them effectively.
• Expertise in creating and maintaining technical documents such as design specifications, validation protocols, and SOPs within the Windchill environment.
• Ability to troubleshoot PLM-related issues effectively and implement solutions that enhance system performance and user experience.
• Experience working cross-functionally with engineering teams, quality assurance departments, regulatory affairs professionals, and other stakeholders to ensure seamless integration of PLM processes.
• Capability to train team members on Windchill functionalities and provide ongoing support to ensure optimal usage of the system across departments.
• Keen eye for detail necessary for maintaining accuracy in documentation critical for compliance with medical device regulations.
• Driver for acquiring resources and building consensus across products.
• Solicits and accepts the ideas of others, fostering an environment conducive to open communication.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Regularly presents complex technical information/analysis clearly and responds to questions from technical staff members and management.

Nice To Haves

• Experience managing projects related to system upgrades or process improvements within a PLM environment is a plus.

Responsibilities

• Oversee and manage all aspects of product data throughout its lifecycle using Windchill, ensuring compliance with industry regulations.
• Develops new processes that have a significant impact on multiple disciplines.
• Contributes to the establishment of business objectives, goals, budgets and costs as requested.
• Ensure that all documentation and processes meet regulatory requirements such as FDA, ISO 13485, and other relevant global standards.
• Maintain high levels of data integrity and security within Windchill, ensuring that sensitive information is protected in accordance with industry regulations.
• Manage product configuration and change control processes to ensure accuracy and consistency across all stages of product development.
• Support cross-functional teams by facilitating collaboration through efficient use of Windchill, enhancing communication between engineering, quality assurance, manufacturing, and regulatory affairs departments.
• Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.
• Provides broad-based direction for subordinates and colleagues within functional area and cross functionally.
• Guides the successful completion of major programs and may function in a project leadership role.
• Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
• Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
• Provide training sessions for staff on best practices in using Windchill effectively while offering ongoing support to troubleshoot issues as they arise.
• Mentors less experienced engineers.
• Continuously assess current PLM processes within Windchill to identify opportunities for improvement that align with both business objectives and compliance requirements.
• Ensure comprehensive documentation management within Windchill for all project phases from design through post-market activities.
• Assist in preparing for internal and external audits by ensuring all necessary documentation is accurate, complete, and readily available within Windchill.
• Generate detailed reports on product data management activities to provide insights into process efficiencies or bottlenecks requiring attention.
• Works on complex issues where analysis requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the establishment of business objectives, goals, budgets and costs.

Benefits

• competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs
• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• 401(k) plan with a matching contribution
• vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager