- Burnsville, MN
The Senior Manufacturing Engineer is a highly collaborative hands-on operations team member for MR-guided interventional catheters and related devices. This role will be responsible for developing and validating efficient quality-oriented manufacturing processes for complex catheters shafts and assemblies. This position is responsible for complying with the company’s quality system requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Serves in a leadership capacity leading a cross functional team to establish a full-scale catheter shaft manufacturing operation.
- Leads planning and execution efforts in carrying out process PFMEA, process development and workflow, equipment sourcing, installation, process characterization, qualification, and validation activities (IQ, OQ, PQ).
- Supports the management of a cross functional team responsible for manufacturing, quality, R&D, and regulatory.
- Provides daily support as needed in manufacturing with focus on disposable products assembly and packaging.
- Identifies and drives continuous improvements focused on quality and cost.
- 7+ years experience in medical device manufacturing with focus on developing and improving catheter manufacturing processes, equipment, and validation.
- Experience authoring and performing PFMEA, Equipment installation, process characterization, qualification, and validation activities. (IQ, OQ, PQ).
- Experience with sourcing and qualifying key suppliers.
- Must have a collaborative and motivational style.
- Demonstrated leadership on project teams.
- Problem solving and strong communication and interpersonal skills are mandatory.
- Understanding of cardiac anatomy and physiology desired.