A Risk Management SME is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery. Remote work. This role leads and enhances risk management processes within the Design and Reliability Assurance Engineering team, ensuring compliance with industry standards, supporting New Product Development and Continuous Improvement projects, and collaborating with cross-functional teams to drive innovation and reliability in medical device engineering.
location: Remote, Remote
job type: Contract
salary: $74.98 - 104.75 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Provide risk management leadership, expertise, guidance, and supervision across all project phases.
- Develop efficient and robust processes, procedures, tools, and technology to improve risk management.
- Lead the development and implementation of Key Performance Indicators (KPIs) and metrics for risk management.
- Conduct SWAT assessments to support continuous improvement of business processes.
- Lead and support NPD, Sustaining Engineering, and Continuous Improvement projects ensuring compliance with ISO 14971 (2019) and IEC 62366 (2015).
- Expertise in Statistical Techniques to support Design of Experiments (DOE), Design Verification, and Design Validation.
- Proficiency in Design for Six Sigma (DFSS) techniques for design optimization and characterization.
- Knowledge of industry best practices and advancements in risk management processes, tools, and technologies.
- Bachelor's Degree in Engineering (Mechanical, Systems, Chemical, or Electrical) or Science (Mathematics, Chemistry).
- 5-7 years of experience in the medical device industry, specializing in Risk Management (ISO 14971) for Class II and III 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 health, an incentive and recognition program, and 401K contribution (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.
