Manufacturing Engineer (Medical Device)

📋 Description

• Lead continuous improvement initiatives to enhance manufacturing efficiency through the development
• Support manufacturing line setup and optimization at contract manufacturing (CM) partners
• Support make-versus-buy evaluations and, when transitioning manufacturing or packout in-house, help
• Manage verifications and validations of new products/devices/tools releases
• Generate protocols and SOPs for final testing, handling, and reporting
• Support R&D systems testing

🎯 Requirements

• Bachelor’s degree in Mechanical, Electrical, BioMedical, Manufacturing, Industrial, or a related
• 3-8 years’ experience in a Manufacturing or Industrial engineering environment with
• Medical device manufacturing experience working within a quality management system (ISO 13485, FDA
• Experience with verification and validations of medical devices, software/tools, and systems
• Proven ability to perform root cause analysis
• Excellent communication and project management skills

🎁 Benefits

• Robust Medical, Dental and Vision Plans
• STD, LTD, Insurance Plans
• HSA and Flexible Spending Accounts
• Safe Harbor 401(k) Plan with 3% Employer Contribution with immediate vesting
• FlexVTO (flexible vacation plans), Paid Sick Leave, 11 Company Holidays
• Home Office Benefits Stipend for Fully Remote Roles