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Sustaining Engineering Manager
2 months ago
Job Summary:
The Manager, Sustaining & Packaging Engineering position is responsible for the organizational development, functional management and performance of the Sustaining & Packaging Engineering group with direct supervisory, development and performance planning responsibilities for the engineering and technician personnel within Sustaining & Packaging Engineering group.
The Manager, Sustaining & Packaging Engineering 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, Sustaining & Packaging Engineering 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:
- Responsible for the organizational development, functional management and performance of the Sustaining & Packaging Engineering group. This includes providing direct supervision, development and performance planning to engineering and technician personnel within the Sustaining & Packaging Engineering group; prepare Performance Plans, Individual Development Plans (IDPs) and conduct mid- and full year Performance Reviews with associates.
- Accountable for leading and driving change order activities related to product design changes, the team supporting the change, and schedule.
- Accountable for packaging and labeling activities for products in development and post-commercialization. Accountable for developing technical SME expertise for both packaging and labeling.
- Develop budgetary estimates and be responsible for the Sustaining & Packaging Engineering departmental budget.
- Prepare presentations and formally present project updates and reviews to senior management.
- Performs other duties as assigned.
QUALIFICATIONS:
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
- 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
Background Experiences
- BS in Engineering or other related technical field with 7 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
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