A Design and Reliability Assurance Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery. Remote work. The Design and Reliability Assurance Engineer leads and executes risk management activities for medical device projects, ensuring compliance with industry standards, driving process improvements, and supporting cross-functional teams in product development and reliability assurance.
location: Remote, Remote
job type: Contract
salary: $79.98 - 111.73 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Provide leadership, expertise, guidance, and supervision in risk management from project initiation to end-of-life.
- Develop and improve risk management processes, procedures, practices, tools, and technology.
- Lead the development and implementation of key performance indicators (KPIs) and metrics for risk management.
- Conduct SWAT assessments to drive continuous improvement in business processes.
- Ensure compliance with ISO 14971 (2019) and IEC 62366 (2015) in risk management activities.
- Expertise in Statistical Techniques for Design of Experiments (DOE), Design Verification, and Design Validation.
- strong background in DFSS (Design for Six Sigma) techniques, including Design Optimization and Characterization.
- Knowledge of industry best practices and advancements in Risk Management methodologies, processes, tools, and technologies.
- Bachelor's Degree in Engineering (Mechanical, Systems, Chemical, Electrical) or Science (Mathematics, Chemistry).
- 5-7 years of experience in the medical device industry, specializing in Risk Management (ISO 14971) for Class II & 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.
