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Engineering
Biomedical Engineer
Burlington, MA
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8 to 12 months, with potential for extension or conversion
Job Summary:
We are seeking an Bio Medical Engineering to support quality and product surveillance activities within a regulated healthcare environment. This role will be responsible for ensuring high-quality documentation, supporting complaint-handling activities, analyzing quality data, and maintaining 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.
Top Skills/Experience:
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 Main Responsibilities:
Responsible for carrying out tasks related to core job responsibilities with little management oversight. May lead goals with cross-functional or broader scope. Provide solutions to a wide range of difficult problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Responsible for demonstration of core competencies and may be measured against some selected leadership competencies in conjunction with growth and development plan. Identify and elevate areas for continuous improvement. May 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. Interacts with employees, manager, and cross-functional peers. May represent team on cross-functional project teams with other functional leaders. Implements tactical activities related to assignment. Able to contribute functional skills and expertise broadly. Directly influences project direction and scope. May lead projects within function. Decisions may have short- and long-term impact.
Education:
Education Level Major/Field of Study or Equivalent Bachelor's Degree (± 5+ years) In life sciences or engineering. An equivalent combination of education and work experience
Experience Details:
Minimum 4 years In Quality or related field. Preferred Healthcare industry and experience in quality function. Utilize understanding of how their function supports the business and of technical/business Competencies to drive continuous improvement results. Demonstrates proven track record utilizing core & technical competencies
Pay Range:
$34 to $38 per hour The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.