Senior Manufacturing Engineer - Bracco Medical Technologies

Bracco • Eden Prairie, MN

6h • Hybrid

About The Position

Why Join Bracco Medical Technologies? 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.

Requirements

• 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, SPC, PFMEA/control plans, and Design Controls–based change management.
• Hands-on experience with manufacturing fixture design, automation and test systems.
• Ability to automate or visualize test data (LabVIEW, Python, Minitab/JMP).
• Strong working knowledge of ISO 13485, FDA QSR (21 CFR 820), Design Controls, and Process Validation.

Nice To Haves

• Lean/Six Sigma (GB/BB) or PMP certification.
• Proficiency in SolidWorks, Fixture/tooling design.
• Familiarity with PLM/ERP/MES systems (Agile PLM, SAP, MES/eDHR).
• Ability to assess automation ROI

Responsibilities

• 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.

Benefits

• Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
• Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level