Our client, a biotech pioneer in organ transplant technologies and therapies, is in immediate need of a Senior Manufacturing Engineer.
- Provide technical expertise and support related to existing and new manufacturing processes.
- Introducing new products and processes into production, including leading Process Development and Process Validation activities
- Creation of Production Documentation including Manufacturing, Inspection and Test Instructions and submit for approval using document change order procedures.
- Creation of Assembly and Component Drawings to support manufacturing and sustaining engineering activities.
- Selection, design, installation and maintenance of Equipment, Tooling, and fixtures used in Production.
- Support Engineering team and Production team efforts to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
- Work with Production Team, Quality Assurance and Design Engineering to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, and CAPA related activities.
- Support continuous improvement project initiatives focused on improving product quality and reducing cost.
- Support Quality with activities related to quality and inspection procedures, incoming inspection methods, measurement system analysis (MSA), first article inspection (FAI), and gage repeatability and reproducibility (GR&R) activities.
- Support all facility related activities for maintaining the Production areas.
- Provide training for production and quality personnel for new and existing processes.
- Serve as strong team player, supporting and assisting supervisor and colleagues when necessary.
- Comply with all work safety rules and regulations.