Manager, Product Lifecycle Engineering

At Terumo Blood and Cell Technologies, our 8,000+ global associates 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 used to collect, separate, manufacture, and process various components of blood and cells. With innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to increasing the number of patients we serve.

About the role

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. 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 role leverages 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.

Responsibilities

• Oversee and manage all aspects of product data throughout its lifecycle using Windchill, ensuring compliance with industry regulations.
• Develop new processes that significantly impact multiple disciplines and contribute to business objectives, goals, budgets, and costs.
• Ensure 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, protecting sensitive information in accordance with industry regulations.
• Manage product configuration and change control processes to ensure accuracy and consistency across all stages of product development.
• Facilitate collaboration through efficient use of Windchill, enhancing communication between engineering, quality assurance, manufacturing, and regulatory affairs departments.
• Present complex technical information and respond to questions from technical staff and management.
• Guide the successful completion of major programs and function in a project leadership role.
• Direct major phases of complex engineering work, devising new approaches to problems encountered in projects.
• Provide training sessions for staff on best practices in using Windchill and offer ongoing support to troubleshoot issues.
• Mentor less experienced engineers.
• Continuously assess current PLM processes within Windchill to identify opportunities for improvement aligned with 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.
• Generate detailed reports on product data management activities to provide insights into process efficiencies or bottlenecks.
• Work on complex issues where analysis requires an in-depth evaluation of variable factors.
• Exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining results.

Requirements

• Bachelor’s degree in engineering or equivalent education and experience sufficient to perform the essential functions of the job.
• Minimum 8 years of experience.
• Two years of GMP manufacturing experience.

Skills

• Windchill Proficiency: Extensive experience utilizing Windchill PLM software for product lifecycle management, including version control, change management, and document control.
• Regulatory Compliance: Strong understanding of regulatory requirements specific to the medical device industry (e.g., FDA regulations, ISO standards).
• Product Lifecycle Management (PLM): Proven ability to manage and optimize product data throughout its lifecycle.
• Technical Proficiency/Documentation: Expertise in creating and maintaining technical documents such as design specifications, validation protocols, and SOPs within Windchill.
• Problem-Solving Skills: Ability to troubleshoot PLM-related issues and implement solutions that enhance system performance and user experience.
• Collaboration Skills: Experience working cross-functionally with engineering, quality assurance, regulatory affairs, and other stakeholders.
• Training & Support: Capability to train team members on Windchill functionalities and provide ongoing support.
• Attention to Detail: Keen eye for maintaining accuracy in documentation critical for compliance.
• Project Management: Experience managing projects related to system upgrades or process improvements within a PLM environment.
• Leadership and Collaboration: Ability to acquire resources, build consensus, and foster an environment conducive to open communication.
• Communication: Demonstrated ability to communicate effectively both verbally and in writing, including presenting complex technical information clearly.

Schedule

Onsite (hybrid) in Lakewood, Colorado. Open to candidates willing to relocate to the area.

Pay

Target pay range: $129,300.00 to $161,600.00 (salary determined by education, experience, knowledge, skills, and abilities of the applicant, internal equity, and market alignment). Target bonus on base: 10.0%.

Benefits

• Competitive total reward offerings including compensation, benefits, and recognition programs.
• Multiple group medical, dental, and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Voluntary programs such as group accident, hospital indemnity, critical illness, and pet insurance.
• 401(k) plan with matching contribution.
• Vacation and sick time programs.

Terumo Blood and Cell Technologies is an Equal Opportunity Affirmative Action Employer. All applicants are afforded equal opportunity without discrimination based on race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status, or unfavorable discharge from military service.