Biomedical Engineer I – Boston Scientific
Boston Scientific is a global leader in medical devices, dedicated to transforming lives through innovative medical solutions. We are seeking a Biomedical Engineer I to join our team in Marlborough, MA, supporting development and testing of next-generation cardiovascular and endoscopy devices.
Responsibilities
- Assist in design verification and validation testing of medical devices per FDA 21 CFR Part 820 and ISO 13485 standards
- Conduct bench-top testing, analyze data, and document results in compliance with design history file requirements
- Support risk management activities including FMEA and hazard analysis documentation
- Collaborate with cross-functional teams (R&D, quality, regulatory) during new product development
- Maintain laboratory equipment and assist in calibration procedures
- Write technical reports, test protocols, and contribute to design documentation
Requirements
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field (May 2025 or recent graduate)
- Familiarity with FDA quality system regulations and ISO standards
- Strong analytical and problem-solving skills
- Proficiency in Microsoft Office; MATLAB or Python a plus
- Excellent written and verbal communication skills
Benefits
- Competitive salary and annual performance bonus
- Comprehensive health, dental, and vision insurance
- 401(k) with generous company match
- Employee stock purchase plan
- Tuition reimbursement and professional development programs