Staff Engineer, Medical Devices — Hybrid (Boston)

Sirtex Medical Limited; Woburn (MA); Hybrid; USD 130,000 - 157,000; Full time

Benefits offered by this job

Diverse and flexible work arrangements

Competitive compensation

401k matching

Job summary

Sirtex Medical Limited in the Boston area seeks an experienced engineer to design and prototype new medical devices, validate designs, and support regulatory documentation for Class II/III products. You will collaborate across medical, scientific, regulatory, manufacturing, marketing, and sales teams to drive projects from concept through confirmation studies, while adhering to Sirtex and FDA standards.

This hybrid role requires local presence 3 days in office and 2 days remote, with opportunity

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering with 6+ years industry experience.
• Masters degree preferred or equivalent years of experience.
• Experience with Class II/III medical devices required.

Responsibilities

• Design and develop new medical devices and prototypes.
• Support research, regulatory, manufacturing, and sales in product design and validation.
• Plan, coordinate, and manage project tasks; develop test methods and documentation.
• Establish product requirements and risk analyses; contribute to regulatory submissions.

Skills

Mechanical design

Biomedical engineering

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Master's degree preferred

Job description

Sirtex Medical Limited in the Boston area seeks an experienced engineer to design and prototype new medical devices, validate designs, and support regulatory documentation for Class II/III products. You will collaborate across medical, scientific, regulatory, manufacturing, marketing, and sales teams to drive projects from concept through confirmation studies, while adhering to Sirtex and FDA standards.

This hybrid role requires local presence 3 days in office and 2 days remote, with opportunity