Job Description

Our client, a medical device company in Boston, is seeking a Biomedical Engineer to support the design and development of innovative healthcare products. This role involves prototyping, testing, and refining medical devices while ensuring compliance with FDA regulations. The position reports to the Senior Engineering Manager and works closely with R&D, quality, and regulatory teams.

The ideal candidate has experience in medical device development and a strong understanding of design controls and regulatory requirements. This is an on-site position at their Longwood Medical Area facility.

Responsibilities

• Design and develop medical devices from concept through commercialization
• Create prototypes and conduct testing to validate design specifications
• Prepare and maintain design history files and technical documentation
• Ensure compliance with FDA regulations and ISO 13485 standards
• Collaborate with cross-functional teams including R&D, quality, and manufacturing
• Conduct risk analysis and implement design improvements
• Support clinical evaluations and post-market surveillance activities
• Stay current with emerging technologies and industry trends

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
• 3+ years of experience in medical device development
• Strong understanding of FDA design controls and regulatory submissions
• Experience with CAD software such as SolidWorks or AutoCAD
• Knowledge of ISO 13485 and IEC 62304 standards
• Familiarity with prototyping and testing methodologies
• Excellent analytical and problem-solving skills
• Strong written and verbal communication skills

Benefits

• Competitive base salary with annual bonus potential
• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off and company holidays
• Professional development opportunities
• Life and disability insurance
• Onsite fitness center
• Tuition reimbursement program

Job Type: Full-Time | Work Type: On-site | Industry: Biotechnology | Experience: Mid-Senior

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