Senior Mechanical Engineer

Mechanical Engineer – Sustaining Engineering

Location: Madison East

Schedule: Full-Time | 40 Hours per Week (M-F) 8 AM to 4 PM

Job Description

We are seeking a detail-oriented and hands-on Mechanical Engineer to support sustaining engineering activities for medical device manufacturing and test systems. This role involves engineering change management, CAD updates, verification activities, manufacturing support, troubleshooting, and collaboration across Operations and Quality teams to ensure product quality, compliance, and continuous improvement.

Key Responsibilities

• Manage and execute Change Controls (MOCs) from Change Request through final closeout using MasterControl.
• Perform CAD changes and design updates using SolidWorks for device component improvements and sustaining engineering projects.
• Includes machined metal, plastic, and sheet metal components.
• Develop and manage verification activities, including:
• Verification plans and protocols
• Execution of testing
• Final results and report documentation
• Route and maintain supporting documentation in MasterControl while ensuring compliance with SOPs and traceability requirements.
• Independently perform part measurements and statistical analysis to evaluate tolerance changes and assembly stack-up tolerances.
• Support manufacturing floor activities by troubleshooting issues, collaborating with Operations and Quality teams, and driving corrective actions through closure.
• Support and assist in the design and development of mechanical enclosures and test system components.
• Read schematics and engineering drawings to specify, source, and build test fixtures.
• Troubleshoot mechanical and system-related issues, identify root causes, and implement corrective actions.
• Ensure compliance with applicable regulations, safety standards, GDP, and GMP requirements.
• Collaborate closely with Engineers and Technicians to coordinate project activities effectively.
• Maintain accurate engineering and manufacturing records following Good Documentation Practices (GDP).
• Provide technical guidance and support to internal teams.
• Follow all workplace safety procedures and protocols.
• Estimate labor and material requirements for mechanical projects and repairs.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering or related engineering discipline.
• Experience with CAD design and engineering documentation.
• Proficiency in SolidWorks.
• Experience supporting manufacturing or sustaining engineering environments.
• Strong troubleshooting, analytical, and problem-solving skills.
• Ability to work cross-functionally with Operations, Quality, and Engineering teams.
• Familiarity with regulated environments and documentation practices.

Preferred Qualifications

• Experience with Geometric Dimensioning & Tolerancing (GD&T).
• Project management experience supporting short- to mid-range projects.
• Familiarity with Windows-based test systems.
• Experience with MasterControl or similar document/change management systems.
• Knowledge of GMP and medical device manufacturing environments.