Job Title: Mechanical Engineer
Location: Westfield, IN
Requirements:
• Collaborates with manufacturing to develop, document, implement, and train staff on high capability manufacturing and test processes.
• Conducts product testing as needed.
• Creates CAD models and prototypes.
• Designs, sources, builds, and debugs fixtures and tooling for manufacturing and product development.
• Analyzes and optimizes manufacturing processes.
• Evaluates and designs components and subassemblies for manufacturability.
• Applies valid industrial research and applied statistics for process control.
• Prepares engineering protocols, executes plan, gathers data, analyzes the results, and writes clear and concise reports.
• Implements basic project management goals, schedules, tracking, and reporting.
• Works within medical device regulations and conforms with the Quality Management System.
• Collaborates with assemblers and technicians to write clear assembly and test procedures and resolve technical issues.
• Participates in structured failure and root cause analysis for issue resolution
.• Develops and executes qualification studies, including verifications and validations.
• Works mostly autonomously but requires direction to accomplish complex projects and tasks.
• Works well in a team setting and interdepartmentally with colleagues.
Qualifications:
• Requires a bachelor's degree of Mechanical Engineering, Industrial Engineering or Manufacturing Engineering or related experience.
• Typically requires 5-7 years of related experience.
• A background in Lean Manufacturing tools and techniques is a plus.
• Must have good SolidWorks modeling and drafting skills per ASME Y14.5.
• Must be proficient with MS 365 tools.
• Must have good 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
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