Job Summary

• Responsible for Software development in compliance with ISO 13485 and IEC 62304 standards including creation of design documentation.
• Coordinate risk strategies for medical devices in compliance with ISO 14971, including use of Failure Mode and Effects Analysis (FMEA) per IEC 60812.
• The company offers a comprehensive benefits package including health, dental, vision insurance, retirement plans, and paid time off for regular employees working 20+ hours per week.

Matching Summary

Salary

$112,000 to $147,600 per year; Not specified; Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps (global well-being program), Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Key Requirements

• Bachelor's degree in related engineering field
• Two (2) years' experience as a software engineer
• Two (2) years' experience with ISO 13485 and IEC 62304
• Two (2) years' experience with ISO 14971 and IEC 60812
• Two (2) years' experience with C# and C++
• Two (2) years' experience with MATLAB, Python, JavaScript, SQLite, MySQL, WiX
• Two (2) years' experience with Azure DevOps and Team Foundation Server
• Two (2) years' experience with AI/ML to medical devices
• Two (2) years' experience developing software for medical devices

Work Rights