Mechanical Engineer - Confidential : Job Details

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