Title: Engineer (Post-Market)
Duration: 11+ months
Location: Burlington, MA 01803
Shift: 8AM - 5PM (M-F)
Main Purpose of Role
Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the Product Analysis Laboratory. Analyses failures, develops, and implements investigative protocols to identify root causes, performs circuit analysis, performs device and component level failure analysis.
Main Responsibilities
- This is a post-market role and not R&D; an entry-level role so no experience is necessary but will take persons with 0 to 2 years of experience, no more than that
- Since this is entry level, managers are looking for new college graduates with internship and capstone project experience only.
- Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.
- Position requires Lab Work & Writing at cubicle - will need to summarize findings into reports that go to FDA. Conducting Failure Analysis on Heart Pumps.
- Experience with blood work in the past is preferred but not required as the person will be working with heart pumps that have been used in the field w/ heart patients or persons that have passed. The heart pumps have been implanted and are covered in blood and sometimes tissue that has begun to decompose while in shipment.
- Perform failure analysis on explanted long-term biomedical implant product.
- Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify route cause failure mechanisms.
- Proactive in finding quality improvements related to Failure Analysis
- May serve as lead and assign work to less experienced personnel and serves as a mentor when assisting less experienced lab staff in solving more complex problems.
- Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.
- Aides in definition of test equipment as required to accomplish quality responsibilities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Will be writing complaints & reports and evaluating the products and testing.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Qualifications
- Bachelor's degree in Engineering is required, preferably in Biomedical or Mechanical Engineering. Will accept fresh college graduates and past interns/co-op experience is desirable; No PhDs, and no Master degreed candidates.
- Knowledge of global regulations for medical device reporting and medical terminology is a positive
- Top skills needed - Strong Communication, Strong Writing, Time Management, and Detail Oriented, MS Office - experience with Excel and Word.
- Will train on their own systems such as EPIQ once hired.
- Strong written and oral communication skills are required
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
- Multitasks, prioritizes, and meets deadlines in a timely manner
- Strong organizational and follow-up skills, as well as attention to detail.
- Interview process will consist of one phone screen of 15 minutes long, and if passes that will move to an in-person interview onsite.
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Spectraforce Technologies
Oct 02, 2024