Are you an experienced Compliance Engineer with a background in the medical device industry? We are looking for a Medical Product Compliance Engineer to ensure that our innovative products meet national and international safety standards. Join a dynamic team and make a significant impact on product safety and compliance!
This contract is for 1 year, possibility to extend or hire on
location: Skaneateles Falls, New York
job type: Contract
salary: $75 - 80 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Review and ensure product compliance with national and international standards.
- Support product development teams by interpreting and applying relevant design standards and directives.
- Resolve compliance issues by collaborating with electrical, mechanical, and software engineering teams.
- Maintain technical files for the product lifecycle and submit compliance reports to safety agencies.
- Review user documentation for accuracy in warnings, labels, and symbols as per standards.
- Evaluate 3rd party technical files to ensure regulatory compliance and certification requirements.
- BS Degree in Electrical or Mechanical Engineering or equivalent experience.
- Minimum of 5 years' experience in the medical device industry, preferably in Compliance Engineering.
- Knowledge of medical safety standards including IEC/EN/UL 60601-1, IEC 60601-1-11, and 60601-1-8.
- Experience with Notified Bodies and agency certifications (e.g., UL, IEC, VDE, CSA).
- Understanding of ISO 14971, FDA, and EU requirements is preferred.
- Excellent communication skills (written and oral) to collaborate across teams.
- Solid problem-solving abilities to address compliance issues efficiently.
- Self-motivated and detail-oriented with high performance standards.
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- 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.
