Engineer 4 - Product Design Lifecycle Engineer (Windchill)

Requisition ID: 32986

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.

The Engineer Level 4 - Windchill Expert is a crucial role within the Product Lifecycle Excellence Team, focusing on the product side. This position plays a pivotal part in our mission to innovate and enhance patient experiences through cutting-edge medical devices.The role possesses advanced expertise in Windchill, utilizing this knowledge to optimize product lifecycle processes. Reporting directly to the Director of Product Lifecycle, the individual will serve as an essential contributor within a dynamic team environment.This role requires a deep application of engineering principles across diverse assignments and demands innovative problem-solving skills. The position develops and evaluates comprehensive plans and criteria for various projects. The engineer will undertake complex research assignments that necessitate the creation of new or enhanced techniques and procedures.Joining this team means being at the forefront of technological advancements in the medical device industry, where contributions have a direct impact on life-saving technologies.

ESSENTIAL DUTIES

• Product Lifecycle Management (PLM): 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.
• Regulatory Compliance: Ensure that all documentation and processes meet regulatory requirements such as FDA, ISO 13485, and other relevant global standards.
• Data Integrity and Security: Maintain high levels of data integrity and security within Windchill, ensuring that sensitive information is protected in accordance with industry regulations.
• Configuration Management: Manage product configuration and change control processes to ensure accuracy and consistency across all stages of product development.
• Collaboration Facilitation: 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.
• Program Management: Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
• Engineering: Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
• Training and Support: 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.
• Process Improvement: Continuously assess current PLM processes within Windchill to identify opportunities for improvement that align with both business objectives and compliance requirements.
• Documentation Management: Ensure comprehensive documentation management within Windchill for all project phases from design through post-market activities.
• Audit Preparation: Assist in preparing for internal and external audits by ensuring all necessary documentation is accurate, complete, and readily available within Windchill.
• Reporting and Analysis: 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.
• Work direction responsibility may include technicians and junior engineers.
• 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.

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's of Science degree or Master of Science degree in Engineering preferred.

Experience

• Minimum 8 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Windchill Proficiency: Extensive experience in 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), ensuring all documentation and processes adhere to these stringent guidelines.
• Product Lifecycle Management (PLM): Proven ability to manage and optimize product data throughout its lifecycle, from conception through design, manufacturing, service, and disposal.
• Technical Proficiency/Documentation: 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.
• Problem-Solving Skills: Ability to troubleshoot PLM-related issues effectively and implement solutions that enhance system performance and user experience.
• Collaboration Skills: Experience working cross-functionally with engineering teams, quality assurance departments, regulatory affairs professionals, and other stakeholders to ensure seamless integration of PLM processes.
• Training & Support: Capability to train team members on Windchill functionalities and provide ongoing support to ensure optimal usage of the system across departments.
• Attention to Detail: Keen eye for detail necessary for maintaining accuracy in documentation critical for compliance with medical device regulations.
• Project Management: Experience managing projects related to system upgrades or process improvements within a PLM environment is a plus.
• Leadership and Collaboration: Driver for acquiring resources and building consensus across products. Solicits and accepts the ideas of others, fostering an environment conducive to open communication.
• 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.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area.

TRAVEL

Requires travel based on business needs.

PHYSICAL REQUIREMENTS

• General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$123,600.00to$154,500.00 -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:10.0%

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 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.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of 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 an unfavorable discharge from military service.

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.