Overview In this role, you lead the Sustaining Engineering group to ensure ongoing product compliance and performance after release. You will manage a cross-functional engineering team, drive change orders for product design updates, and oversee budgets and performance planning. You'll develop SME capabilities in design control and V&V, and communicate progress to senior management. This is an opportunity to shape the lifecycle of critical medical devices within a global, quality-focused organization.
Compensation / Benefits- annual bonus
- health, dental and vision benefits
- 401(k) with matching
- parenteral leave
- tuition reimbursement
- employee assistance program
Responsibilities- Provide organizational development and performance management for the Sustaining Engineering group
- Develop and monitor Performance Plans and IDPs; conduct reviews
- Lead change order activities for product design changes and manage the supporting team and schedule
- Ensure products remain compliant with new and existing standards
- Develop or hire SME expertise in design control and product changes
- Develop departmental budget and manage budget execution
- Prepare presentations and present project updates to senior management
- Perform other duties as assigned
Key requirements- BS in Engineering or related technical field with 7 years of medical device product development experience
- Experience in cross-functional development and transfer of products to manufacturing and commercialization
- Ability to manage design changes and assess V&V activities related to form, fit, function, and performance
- Strong communication skills (verbal and written)
- Experience in budgeting and resource planning
- Functional management and organizational development experience
- effective communicator
- leadership and mentoring
- cross-functional collaboration
- medical device product development
- design control
- verification and validation (V&V)
