Job Abstract

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.
 

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.
 

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.

• • 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

• • 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