Senior Manufacturing Engineer will lead sustaining engineering activities to ensure safe, compliant, and efficient manufacturing of medical devices. This role will be responsible for driving continuous improvement, troubleshooting production issues, and supporting change management activities while ensuring adherence to internal quality system requirements. The role partners closely with Operations, Quality, R&D, and Suppliers to improve yield, optimize processes, and support product lifecycle objectives. Team members shall receive minimal supervision and are viewed as subject matter experts.

What you will do:

• Lead and execute process validation activities, IQ/OQ/PQ, for manufacturing processes, equipment, and test methods to ensure continued compliance and product quality.
• Develop, author, review, and approve validation protocols, reports, and supporting manufacturing documentation meeting internal quality system requirements.
• Assess and implement revalidation strategies driven by process changes, non-conformances, CAPAs, production metric trends, or continuous improvement initiatives.
• Troubleshoot manufacturing production and equipment issues related to existing established processes and directly work with cross-functional team members to implement corrective actions.
• Directly support change management activities, which will include performing risk assessments and assessing the impact on validated processes and products, equipment, and material changes.
• Support and drive Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations.
• Support Kaizen and continuous improvement events.
• Participate in internal/external audits by providing validation expertise and general guidance on existing manufacturing processes.
• Mentor entry-level to junior engineers and provide technical guidance.

Minimum Qualifications:

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline.
• Minimum 2 years of engineering experience.

Preferred Qualification:

• Catheter and/or medical device
• Proficiency in SolidWorks for creating and modifying production-released models and drawings.
• Experience designing manufacturing fixtures, gauges, and test setups.
• Understanding of design for manufacturing (DFM) principles to support yield improvements and manufacturing robustness.
• Capable of performing tolerance analysis and stack-ups.