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Manufacturing Engineering Manager
1 week ago
The primary function of this position is to manage a team of engineers and technicians focused on process improvements of devices post release to market and/or the introduction of new products (NPI), for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.
Responsibilities- Lead a team of engineers focused on manufacturing engineering areas such as CAPA, Design, Manufacturing or NPI.
- Provide leadership and mentoring to team members to ensure their development and the effective completion of activities associated with their role.
- Mentor and coach direct reports to attain best performance.
- Manage team activities and hold regular meetings.
- Ensure Key Performance Indicators (KPIs) and business metrics are achieved.
- Work with senior engineers to allocate resources and prioritize efforts for the overall manufacturing engineering team.
- Collaborate with other manufacturing engineering team members to ensure effective completion of all activities associated with a manufacturing engineering project or objective.
- Ensure effective reporting to the manufacturing engineering manager.
- Identify and implement process changes that improve existing device quality, performance, and efficacy.
- Implement cost reduction and yield/efficiency improvement opportunities.
- Provide engineering input and support for investigation and resolution of Non Conformances associated with devices post release to market.
- Support Regulatory Affairs with engineering input for process-related submissions and renewals post initial release of devices to market.
- Responsible for process engineering layout plans and implementation in relation to line extensions or redesign.
- Support post-market surveillance of devices in terms of complaint investigation and risk analysis.
- Guide engineers and technicians focused on support and timely completion of CAPAs (related to design, procedures, and systems, or manufacturing processes).
