Process Engineer - Tool Design

Duties & Responsibilities

• Partners with management to establish production goals and ensure achievement of key performance metrics related to safety, quality, delivery, and cost.
• Provides daily production support, including troubleshooting, answering operator questions, and delivering hands-on training to ensure efficient operations.
• Designs, develops, and implements fixtures and tooling to be used in manufacturing processes and inspections.
• Creates and implements CAD packages using Creo CAD Software.
• Acts as a subject matter expert (SME) in supporting complex equipment (i.e. 5 Axis mills, waterjets, mechanical assemblies, CNC programming (Solid Cam)).
• Supports Lean activities including Kaizen events, 5S, visual management, and process/value stream mapping to improve safety, quality, delivery, and cost.
• Writes, revises, and trains personnel to work instructions, procedures, validation protocols, validation reports, and other similar documentation.
• Performs other job-related duties as assigned (i.e. NCR, ECOs, CAPAs, Scrap Tracking Metrics, Lean, Standup Meetings, etc.).

Qualifications

• Knowledge of FDA/ISO regulations and medical device manufacturing.
• Design tools and fixtures to manufacture medical devices.
• Strong proficiency in Creo CAD Software (i.e. 3D Models, Drawings, Assemblies).
• Direct hands-on troubleshooting equipment experience (i.e. waterjets, CNC machines, mechanical assemblies, etc.).
• Proficient in Microsoft Office.
• Team-oriented, adaptable, and able to learn new systems and tools quickly.
• Strong organization, attention to detail, and communication skills.

Benefits

• Medical
• Vision
• Dental
• Health savings accounts with employer contribution
• Flexible spending account options
• Company-paid life insurance policy
• Paid time off
• Company holidays
• Floating holidays
• 100% company-paid short & long-term disability
• 401k match up to 3.5%
• Paid parental leave