A Risk Management Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery in multiple locations. This Subject Matter Expert role leads the technical remediation of medical device risk and usability documentation to ensure compliance with EU MDR standards, utilizing advanced statistical analysis and cross-functional leadership to maintain patient safety and product market access.
location: Mansfield, Massachusetts
job type: Contract
salary: $62.70 - 87.59 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Acts as a Subject Matter Expert (SME) within the Design Quality Assurance team focusing on Risk Management and Usability.
- Conducts comprehensive gap assessments of existing technical documentation to ensure alignment with EU MDR requirements.
- Ensures compliance with international standards, specifically ISO 14971:2019 (Risk Management) and IEC 62366-1:2015 (Usability Engineering).
- Leads the planning, organization, and execution of usability studies and risk-related activities across the product lifecycle.
- Collaborates with cross-functional partners in Regulatory Affairs, Medical Affairs, and Manufacturing Engineering to remediate legacy product files.
- Develops and implements robust processes, tools, and technologies to drive continuous improvement in risk management practices.
- Establishes and monitors key performance indicators (KPIs) and metrics to track the health of the risk management process.
- Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring.
- Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.
- Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
- 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
