Sustaining R&D Engineer, Medical Devices

Hologic, Inc.; Marlborough (MA); Hybride; USD 78 000 - 122 000; Plein temps

Résumé du poste

Hologic, Inc. in Marlborough, MA is seeking an R&D Engineer, Sustaining to drive lifecycle management of medical devices, lead design changes, verification testing, and documentation updates while ensuring performance and regulatory compliance.

The role collaborates with Quality, Regulatory, Clinical, Manufacturing, and Operations to resolve issues, implement product enhancements, and sustain released products through rigorous engineering and CAPA processes.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related field.
• Minimum 2 years of engineering experience in medical devices or highly regulated settings.
• Experience with CAD tools (SolidWorks) and Altium Designer.
• Hands-on prototyping, 3D printing, machining, soldering, lab skills.
• Experience with design controls, CAPA, risk management, and regulatory compliance.

Responsabilités

• Support sustaining R&D activities across product lifecycle, including enhancements and obsolescence management.
• Perform root cause analyses for complex product, manufacturing and field issues with corrective actions.
• Coordinate engineering studies, verification testing and product evaluations for design changes.
• Analyze data, test results, and feedback to drive data-based decisions.
• Translate needs into engineering requirements, specifications and controlled docs.
• Prepare technical reports, risk evaluations, and recommendations for teams and management.

Connaissances

Root cause analysis

CAD design

Data analysis

Prototyping

Cross-functional collaboration

Problem solving

Formation

Bachelor’s degree in Mechanical or Electrical Engineering

Experience in medical device industry or regulated environment

Outils

SolidWorks

Altium Designer

Description du poste

Hologic, Inc. in Marlborough, MA is seeking an R&D Engineer, Sustaining to drive lifecycle management of medical devices, lead design changes, verification testing, and documentation updates while ensuring performance and regulatory compliance.

The role collaborates with Quality, Regulatory, Clinical, Manufacturing, and Operations to resolve issues, implement product enhancements, and sustain released products through rigorous engineering and CAPA processes.