Manufacturing Engineer

at  Podimetrics

Job Title: Manufacturing Engineer
Location: On-Site in Somerville, MA
Reports to: VP, Manufacturing and Fulfillment
Department: Device Operations
Key Relationships: Device Operations, Engineering, and Manufacturing

EDUCATION & EXPERIENCE

• Bachelor’s degree (B.S.) in Mechanical Engineering or related Engineering Degree.
• Minimum of five (5) years hands-on related experience in manufacturing environment.
• Background in medical diagnostics / medical devices preferred.
• Strong mechanical aptitude / hands on for troubleshooting and repairs.
• Experience with CAD, Excel and statistical software..
• Detailed, meticulous application of engineering principals.
• Available for travel

ABOUT THE ROLE

We are seeking a highly driven, analytical and methodical Manufacturing Engineer to work closely with our manufacturing partner to support all aspects of manufacturing operations. The Manufacturing Engineer will work closely with Device Operations department on a day-to-day basis. The ideal candidate will collaborate across functions to effectively support manufacturing operations, spearhead product and process improvements and maintain compliance with applicable regulations.

KEY RESPONSIBILITIES

• Collaborate with Manufacturing, Engineering, Quality and R&D personnel to support manufacturing operations.
• Interface with contract manufacturing staff to ensure manufacturing lines are up and running efficiently.
• Exhibit good documentation habits exceeding the requirements of the medical diagnostics industry.
• Generate formal reports and presentations to support Quality System and business needs.
• Conduct risk analysis and perform product and process verification and validation activities for revisions and new devices.
• Work effectively with outside vendors of materials and equipment to make corrections and improvements to supplied components.
• Supervise and perform maintenance to production equipment.
• Monitor manufacturing processes and analyze the manufacturing line and equipment for problems’
• Perform root cause analysis and work towards resolutions.
• Conduct design of experiments approach for assessing mechanical and product-based performance.
• Develop and fabricate, test fixtures for manufacturing processes.
• Recommend design changes, cost reductions, reliability improvements, and manufacturing efficiency improvements.
• Write product specifications, document test results, prepare product operating instructions and review technical literature.
• Write manufacturing work instructions, equipment maintenance instructions.
• Participate in Factory Acceptance / Site Acceptance testing activities.
• Provide leadership, mentorship, and support among team member