Bracco Medical Technologies · 15 hours ago
Senior Manufacturing Engineer
Eden Prairie, MN
Full-time
Onsite
Senior Level
$112K/yr - $123K/yr
5+ years expBracco Medical Technologies is committed to fostering a supportive work environment for its employees. The Senior Manufacturing Engineer will lead operational excellence and manufacturing support, ensuring the efficient production of medical devices while collaborating with cross-functional teams to optimize processes and resolve issues.
Medical DeviceHealthcareManufacturingMedical
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
Qualification
Required
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
Preferred
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
Benefits
Paid Time Off, Company Holidays & Paid Family Leave
Annual incentive plan and 401k savings plan contributions
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.
Structured on-the-job learning, workshops, seminars, and our tuition reimbursement program
Company
Bracco Medical Technologies
Bracco Medical Technologies is a medical device, contrast agent, and diagnostic imaging product company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Bradley Fox
Chief Executive Officer
Recent News
Company data provided by crunchbase