Senior Advanced Manufacturing Engineer, Medical Devices

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

Job summary

Hologic, Inc. is seeking a Lead Advanced Manufacturing Engineer to drive manufacturability, design transfer, and process validation for new products. The role requires technical leadership across subsystems, liaison between product development and manufacturing, and mentoring of engineers.

You will develop manufacturing processes, tooling, and fixtures from feasibility to production release, leading pilot builds and risk mitigation throughout the lifecycle.

Qualifications

• Bachelor-level degree in an engineering field with manufacturing or process development experience in medical devices.
• 8 years of experience in health or related sectors with a bachelor’s, or 6 years with a master’s degree.

Responsibilities

• Lead advanced manufacturing engineering across large, complex projects, defining strategy, process architecture, and transfer plans.
• Collaborate between Product Development and Manufacturing to drive DFM and cost targets.
• Develop and qualify processes, tooling, and fixtures from feasibility to production release.
• Lead pilot builds, design transfer, and IQ/OQ/PQ, and conduct MSA and capability studies.
• Prepare project scopes, budgets, and schedules; mentor engineers; present technical decisions.

Skills

DFM/DFA/DFI

Process validation

Risk management

Design transfer

DOE (Design of Experiments)

Minitab

CP/Cpk

GD&T

SolidWorks

Problem solving

Documentation

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Manufacturing Engineering

Bachelor's Degree in Biomedical Engineering

Master’s Degree (preferred)

Tools

SolidWorks

Minitab

Job description

Hologic, Inc. is seeking a Lead Advanced Manufacturing Engineer to drive manufacturability, design transfer, and process validation for new products. The role requires technical leadership across subsystems, liaison between product development and manufacturing, and mentoring of engineers.

You will develop manufacturing processes, tooling, and fixtures from feasibility to production release, leading pilot builds and risk mitigation throughout the lifecycle.