Bio Medical Engineering

Location: Burlington, MA 01803 | Work Arrangement: 100% Onsite

About the role

We are seeking a Bio Medical Engineer to support quality and product surveillance activities within a regulated healthcare environment. This role will ensure high-quality documentation, support complaint-handling activities, analyze quality data, and maintain compliance with applicable worldwide regulatory requirements.

The ideal candidate will have 4+ years of experience in Quality or a related field, preferably within the healthcare or medical device industry, along with strong experience in complaint handling, medical writing, regulatory compliance, data analysis, and cross-functional collaboration.

Responsibilities

• Carry out tasks related to core job responsibilities with little management oversight; may lead goals with cross-functional or broader scope.
• Provide compliant, innovative, thorough, and practical solutions to a wide range of difficult problems consistent with organizational objectives.
• Demonstrate core competencies and may be measured against selected leadership competencies in conjunction with a growth and development plan.
• Identify and elevate areas for continuous improvement.
• Perform other duties as assigned; may provide oversight to one or more QA professionals and/or contractors.
• Scope limited to one specific QA function but has general knowledge of other related disciplines.
• Interact with employees, manager, and cross-functional peers; may represent the team on cross-functional project teams with other functional leaders.
• Implement tactical activities related to assignment; contribute functional skills and expertise broadly.
• Directly influence project direction and scope; may lead projects within the function.
• Decisions may have short- and long-term impact.

Requirements

• Minimum 4 years of experience in Quality or a related field.
• Preferred experience in the healthcare industry and in a quality function.
• Experience with complaint handling, medical writing, and cross-functional communication.
• Regulatory knowledge and compliance expertise.
• Data analysis skills with ability to use tools such as Excel and Power BI.
• Utilize understanding of how their function supports the business and technical/business competencies to drive continuous improvement results.
• Proven track record utilizing core and technical competencies.

Qualifications

Bachelor’s Degree (± 5+ years) in life sciences or engineering, or an equivalent combination of education and work experience.

Pay

$34 to $38 per hour

Schedule

Monday–Friday | 40 hours/week | Daytime hours | Contract duration: 8 to 12 months, with potential for extension or conversion

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time
• Paid vacation time
• Paid parental leave
• Paid holidays annually

Benefits are subject to applicable eligibility requirements.