Senior Manufacturing Engineer

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

The Senior Manufacturing Engineer is a hands-on technical lead with a primary focus on Operational Excellence & Manufacturing Support, followed by process development and manufacturing test. The role ensures stable, compliant, and efficient manufacturing of electro-mechanical medical devices. This role, which will provide an on-the-floor presence and strong cross-functional influence, will partner closely with Production, R&D, Quality, and Regulatory to resolve issues, optimize throughput, improve yield, and transfer robust processes and test systems into production.

• Serve as the first-line technical owner for assigned product lines and value streams, providing daily support for NC/MRB resolution, ECO/CO execution, rework development, design implementation, troubleshooting, and line balancing.
• Lead structured problem-solving efforts (5-Why, Fishbone, Fault Tree) and drive CAPA completion with data-backed effectiveness verification (SPC, Cpk/Ppk, trend analysis).
• Execute continuous improvement projects and initiatives—kaizen/A3 events, waste elimination, OEE/uptime improvement, cycle time reduction.
• Update PFMEA, control plans, and risk documentation to maintain compliance with QMS requirements.
• Design, fabricate/source, and document manufacturing fixtures, tooling, semi-automation solutions, and ergonomic workstations.
• Partner with suppliers and contract manufacturers on process capability, qualifications, and change control.
• Influence cross-functional decisions using data, structured problem solving, and clear communication.
• Maintain a strong on-the-floor presence to support operators, troubleshoot issues, and ensure stable daily performance.

• Drive DFM/DFA and manufacturability considerations early in product development; shape part strategies, assembly flow, ergonomics, and automation opportunities.
• Lead process and line concepting (layouts, takt modeling, throughput modeling), proof-of-principle builds, and DOE activities to establish robust process windows for CTQs.
• Design, source, and document fixtures, tooling, semi-automation solutions, and ergonomic workstations.
• Author and execute IQ/OQ/PQ protocols for processes, equipment, and fixtures, including sampling plans, statistical justification, and revalidation criteria.
• Manage process transfer activities into production, including pilot builds, ramp-to-rate, FPY stabilization, and documentation readiness under Design Controls.
• Mentor technicians and junior engineers in ME fundamentals and best practices.

• Develop new manufacturing test fixtures and systems for new products in close partnership with R&D. R&D owns test requirements and early prototypes; the Manufacturing Engineer converts these into robust, production-ready solutions.
• Improve, upgrade and modernize legacy testers by refining hardware, software, instrumentation, and data collection approaches to reduce variation, improve uptime, and enhance diagnostic capability.
• Lead TMV/MSA efforts (Gage R&R, correlation, linearity, repeatability) for both new and legacy systems to ensure accurate, reliable measurement performance.
• Perform periodic tester verification checks, trend performance data, and drive corrective actions to maintain validated state and ensure long-term stability.
• Author and execute IQ/OQ/PQ protocols for new and updated test fixtures and systems, providing clear, audit-ready documentation aligned with ISO 13485 and FDA expectations.

Minimum

• BS in Manufacturing, Mechanical, Industrial Engineering, or related field.
• Minimum of 5 years of experience in a regulated manufacturing environment; medical device strongly preferred.
• Strong background in production support, troubleshooting, and maintaining validated manufacturing processes.
• Demonstrated expertise in IQ/OQ/PQ, DFM/DFA, DOE,…