Staff Engineer, Medical Devices - Hybrid (Boston)

SmartRecruiters, Inc.; Boston (MA); Hybrid; USD 130,000 - 157,000; Full time

Benefits offered by this job

401k matching

Hybrid work policy

Health insurance

Job summary

Sirtex Medical is seeking a senior engineer to lead product design, prototyping, and validation activities. The role includes bench-testing, data analysis, and root-cause investigations to ensure robust medical devices meet regulatory standards.

Candidates must be local to Boston and able to comply with a 3-day in-office, 2-day remote hybrid policy. A minimum 6+ years in engineering with medical device experience is required.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering or related field.
• 6+ years of industry experience; Master’s degree preferred.
• Experience designing Class II and Class III medical devices or combination products is required.
• Experience working in a cross-divisional enterprise model.

Responsibilities

• Design and develop new medical devices through prototyping and bench-testing.
• Support regulatory, manufacturing, marketing, and sales with product research and design.
• Plan, schedule, and coordinate project tasks and activities.
• Conduct design investigations using structured problem-solving methods.
• Create working prototypes and perform empirical analyses with design tools.
• Collaborate with outside consultants, suppliers, and clinicians on projects.
• Establish product requirements, test methods, and verification protocols.
• Prepare documentation for regulatory submissions and internal quality systems.

Skills

Mechanical design

Biomedical engineering

Project management

Cross-functional collaboration

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Master's degree preferred

Tools

CAD software

Prototype testing equipment

Regulatory documentation tools

Job description

Sirtex Medical is seeking a senior engineer to lead product design, prototyping, and validation activities. The role includes bench-testing, data analysis, and root-cause investigations to ensure robust medical devices meet regulatory standards.

Candidates must be local to Boston and able to comply with a 3-day in-office, 2-day remote hybrid policy. A minimum 6+ years in engineering with medical device experience is required.