Senior Manufacturing Engineer - Bracco Medical Technologies

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.

Primary Duties & Responsibilities:

Operational Excellence & Manufacturing Support

• 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.

Process Development

• 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.

Manufacturing Test (New & Legacy technologies)

• 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.

Qualifications (Knowledge, Skills & Abilities):

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.

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

Estimated Starting Salary Range: $112,000 - 123,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

• 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.

Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.