Senior MedTech Advanced Manufacturing Engineer

Hologic, Inc.; Louisville (KY); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic, Inc. seeks a Lead Advanced Manufacturing Engineer to spearhead development, qualification, and transfer of manufacturing processes for new products.

You will lead strategy across subsystems, drive DFM/DFA, and collaborate with R&D to meet milestones. You will mentor engineers, manage pilot builds, validation (IQ/OQ/PQ), and risk tools, while partnering with sourcing and suppliers to optimize cost and manufacturability.

Qualifications

• Bachelor’s Degree required with manufacturing or process development experience in the medical device industry.
• 8 years of work experience with a Bachelor's Degree.
• 6 years of work experience with a Master's Degree.

Responsibilities

• Lead advanced manufacturing engineering for large, complex projects, including manufacturing strategy, process architecture, and design transfer across subsystems.
• Liaison between Product Development and Manufacturing teams.
• Lead DFM/DFA/DFI reviews with R&D and drive manufacturability, capability, and cost requirements into product design.
• Develop and qualify manufacturing processes, tooling, and fixtures from feasibility to production release.
• Lead technical project meetings and present to support technical decisions.
• Collaborate cross-functionally to develop methods and processes that improve results.
• Mentor and develop other engineers and ensure compliance with procedures.

Skills

DFM/DFI

Design transfer

IQ/OQ/PQ

Process validation

SolidWorks

DOE

Statistical methods

Tolerance stackups

CAD

Lean Six Sigma

Education

Bachelor's Degree in Mechanical/Manufacturing/Biomedical Engineering or related

Tools

SolidWorks

Job description

Hologic, Inc. seeks a Lead Advanced Manufacturing Engineer to spearhead development, qualification, and transfer of manufacturing processes for new products.

You will lead strategy across subsystems, drive DFM/DFA, and collaborate with R&D to meet milestones. You will mentor engineers, manage pilot builds, validation (IQ/OQ/PQ), and risk tools, while partnering with sourcing and suppliers to optimize cost and manufacturability.