Position: Senior Manufacturing Engineer
Reports to: Manufacturing Engineering Manager
ESSENTIAL TASKS AND DUTIES INCLUDE:
• Manufacturing Engineering and Sustaining Engineering activities associated with the production of System Products.
• 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.
• Must have manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.
• Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans to support new and existing process and test equipment.
• Must be detailed oriented with strong organizational skills and interpersonal skills with outstanding ability to communicate clearly and effectively.
• Must possess a strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.
• BS in Engineering plus 6-10 years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry, or equivalent education and years of experience.
Valid through: 12/10/2021