Sr Mechanical Engineer- Laser Welding

Our client is looking for a mechanical engineer to design, develop, and test all aspects of mechanical components, equipment, and machinery related to the development, manufacturing, and approval of an active implantable Class III medical device. This job is structured under hardware engineering and is primarily responsible for all laser welding manufacturing processes, as well as for product testing.

Duties and Responsibilities
• Leads the development and maintains all laser welding processes.
• Develops, validates, and implements weld schedules into production.
• Analyzes welds using various industry standards to ensure reliabilty.
• Conducts product testing as needed.
• Designs, sources, builds, and debugs fixtures and tooling for manufacturing and product development.
• Creates CAD models and prototypes.
• Analyzes and optimizes manufacturing processes.
• Evaluates and designs components and subassemblies for manufacturability.
• Prepares engineering protocols, executes plan, gathers data, analyzes results, and writes clear and concise reports.
• Works within medical device regulations and conforms with the Quality Management System.
• Collaborates with manufacturing to develop, document, implement, and train staff on high-capability manufacturing and test processes.
• Participates in and leads structured failure and root cause analysis for issue resolution.
• Develops and executes qualification studies, including verifications and validations.
• Works autonomously, as well as in team settings and interdepartmentally.

Qualifications:
• Requires 7+ years of related experience.
• Hands on laser welding experience is requiredWorking knowledge of fluids, especially pumps, and associated test systems. Microfluidics is a plus.
• Must have advanced SolidWorks modeling and drafting skills per ASME Y14.5.
• Must be proficient with MS 365 tools.
• Must have strong oral and written communication skills.
• Must have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and work must conform with the Quality Management System.