Mgr., Product Continuity, Packaging & Labeling

Date: Jul 9, 2024

Req ID: 3437

Location:

Elkton, MD, US

Company: Terumo Medical Corporation

Department: Engineering

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

The Manager, Product Continuity and Packaging position, reporting to the Director of Product Life Cycle Management, is responsible for the organizational development, functional management and performance of the Product Continuity and Packaging group with direct supervisory, development and performance planning responsibilities for the engineering and technician personnel within Product Continuity and Packaging group.

The Manager, Product Continuity and Packaging will be accountable for managing post-release product changes relating to form, fit, function, or performance that relate to product requirements changes such as potentially affecting device usability, dimensional, material, or regulatory standards.

The Manager, Product Continuity and Packaging will also be responsible for managing pre and post release packaging and labeling activities, both during development and post-commercialization. This function will perform development, characterization, and verification and validation activities throughout the project and product lifecycle as it relates to packaging and labeling.

Job Details/Responsibilities

1. Responsible for the organizational development, functional management and performance of the Product Continuity and Packaging group. This includes providing direct supervision, development and performance planning to engineering and technician personnel within the Product Continuity and Packaging group; prepare Performance Plans, Individual Development Plans (IDPs) and conduct mid- and full year Performance Reviews with associates.

2. Accountable for leading and driving change order activities related to product design changes, the team supporting the change, and schedule.

3. Accountable for packaging and labeling activities for products in development and post-commercialization. Accountable for developing technical SME expertise for both packaging and labeling.

4. Develop budgetary estimates and be responsible for the Product Continuity and Packaging departmental budget.

5. Prepare presentations and formally present project updates and reviews to senior management.

6. Performs other duties as assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

This position will be located in the Terumo facility located in Elkton, MD. The position will perform required duties mainly in an office environment that is adjacent to manufacturing operations. Access to hospitals and hospital operating rooms will be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.

Knowledge, Skills and Abilities (KSA)

• Extensive experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.

• Demonstrated understanding of the cross-functional interactions needed for the development and change management of products within medical device industry design control guidelines

• Effective communication skills, both verbal and written.

• Ability to develop budgetary estimates and manage their execution.

• Functional management and organizational development experience in managing an Engineering group and in preparing Performance and Development Plans and reviews.

• SME understanding of design, verification and validation (V&V) approaches, packaging, and/or labeling

Qualifications/ Background Experiences

• BS in Engineering or other related technical field with 10+ years of Medical Device product development experience.

• Demonstrated understanding of the roles and responsibilities of the cross-functional activities needed to successfully develop new and transfer existing products to manufacturing and release for commercialization.

• Demonstrated ability to manage design changes and assess engineering V&V activities related to product, packaging, and labeling form, fit, function, and performance

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.