Product Regulatory Compliance Engineer
United States1w ago
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Key details
- Salary
- $104K–$133K/yr
- Location
- United States
- Work style
- Remote
- Level
- Senior
- Experience
- 5–8 yrs
- Function
- Software engineering
- Focus area
- other
- Posted
- 1w ago
Skills
compliancelaboratory testingproduct designregulatory compliance
About the role
POSITION SUMMARY
The candidate must be a self-motivated, independent engineer with a broad understanding of regulatory specifications and requirements. The Compliance Engineer will be responsible for evaluating Alaris product designs to ensure compliance with global regulatory requirements. The individual must be able to manage schedules for compliance between external vendors and the internal team in a product commercialization environment. Occasional travel to the home office in Rochester, NY is required.
ESSENTIAL RESPONSIBILITIES
Evaluate designs and assess for compliance with global regulations
Perform technical reviews and gap assessments
Provide compliance guidance to engineering during design phase and operations team during production phase.
Evaluate regulatory requirements of custom engineering and OEM design proposals.
Support submissions for regulatory compliance based on testing reports.
Manage external lab testing and compliance contractors.
Work with the production quality team in the event of a notification of non-compliance.
Develop and support test plans for Engineering and Production teams.
Stay up to date on the latest standards and changes in regulatory landscape.
Operate test equipment as necessary to assist in resolving non-compliance issues.
Travel to support compliance testing at external labs, up to 10%.
SKILLS AND/OR KNOWLEDGE SPECIFICATIONS
Strong communication skills to support technical document creation and review.
Demonstrated knowledge of common electrical, mobile, wireless and battery regulations, both domestic and international in scope, including FCC, CE, IEC, VCCI, UN38.3, etc.
Knowledge of international product safety standards including CE, WEEE, RoHS, REACH, UL, etc.
Ability to multi-task and manage time effectively.
Proven experience managing external vendors.
EDUCATION AND/OR EXPERIENCE SPECIFICATIONS
5+ years experience in design or test of consumer or commercial products
3+ years experience in Regulatory Compliance
Bachelor's degree or greater in Electrical Engineering or equivalent from an accredited program
Compensation: $104,000 - $133,000 – based on level of experience
The candidate must be a self-motivated, independent engineer with a broad understanding of regulatory specifications and requirements. The Compliance Engineer will be responsible for evaluating Alaris product designs to ensure compliance with global regulatory requirements. The individual must be able to manage schedules for compliance between external vendors and the internal team in a product commercialization environment. Occasional travel to the home office in Rochester, NY is required.
ESSENTIAL RESPONSIBILITIES
Evaluate designs and assess for compliance with global regulations
Perform technical reviews and gap assessments
Provide compliance guidance to engineering during design phase and operations team during production phase.
Evaluate regulatory requirements of custom engineering and OEM design proposals.
Support submissions for regulatory compliance based on testing reports.
Manage external lab testing and compliance contractors.
Work with the production quality team in the event of a notification of non-compliance.
Develop and support test plans for Engineering and Production teams.
Stay up to date on the latest standards and changes in regulatory landscape.
Operate test equipment as necessary to assist in resolving non-compliance issues.
Travel to support compliance testing at external labs, up to 10%.
SKILLS AND/OR KNOWLEDGE SPECIFICATIONS
Strong communication skills to support technical document creation and review.
Demonstrated knowledge of common electrical, mobile, wireless and battery regulations, both domestic and international in scope, including FCC, CE, IEC, VCCI, UN38.3, etc.
Knowledge of international product safety standards including CE, WEEE, RoHS, REACH, UL, etc.
Ability to multi-task and manage time effectively.
Proven experience managing external vendors.
EDUCATION AND/OR EXPERIENCE SPECIFICATIONS
5+ years experience in design or test of consumer or commercial products
3+ years experience in Regulatory Compliance
Bachelor's degree or greater in Electrical Engineering or equivalent from an accredited program
Compensation: $104,000 - $133,000 – based on level of experience