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Sr. Compliance Engineer 3 - Contractor

Date:  03-Aug-2022
Location:  Connecticut
State:  Danb
Country:  US
Company:  LTTS

You will be responsible for ensuring  medical products meet all applicable EMC/EMI and safety compliance standards for  global markets throughout the product lifecycle – including design for compliance, certification, and global regulatory compliance – such as EU MDR.  You will collaborate with R&D engineers, Regulatory Assurance, and Design Assurance, as well as with external Test Labs such as UL, CSA, or Certified Agencies.

Successful candidate will work independently with little direction. Lead and coordinate compliance tasks with other internal functions and external test agencies & labs, and provide guidance on compliance testing, scheduling, and compliance definition appropriate for the product line, such as IEC 60601-1 & -2 or IEC 61010 – including filling out the IEC 62304 and 62366 templates for new Medical products.
Apply project management and problem-solving skills to complete multiple product activities concurrently.

As a Sr. Compliance Engineer, you’ll provide time critical solutions to our customers, and navigate across functions and business operations to influence positive outcomes. May provide guidance to Program Management, Regulatory Assurance, and R&D staff for regulatory interpretation.
 Detailed responsibilities are: 

• During early program phases the Compliance Engineer will support:
o Marketing & Regulatory’s efforts to identify applicable regulatory compliance requirements, and provide technical translation of requirements to R&D teams
o Work with Marketing, Systems, and Engineering teams to implement requirements into product definitions
o Create Compliance Program Plans
• During all program phases the applicant will support:
o Oversee EMC, & environmental pre-compliance and compliance testing at Certified Test Labs
o Oversee IEC 60601-1 compliance testing
o Act as the Hologic compliance liaison to Test Labs and Certified Agencies – e.g. UL, CSA, TUV, BSI.
o Develop EMC & Safety Certification test plans, Verification Procedures and Reports
o Define compliance re-testing needs based on design changes
o Participate in internal failure investigation and design changes where they arise during Compliance testing
• Before product launch the applicant will deliver:
o Product certifications, through 3rd party testing, to required standards
• Following product launch the applicant will:
o Support product post-launch changes (e.g., regulatory changes, product evolution, corrective actions) to ensure on-going compliance.
o Support UL inspection audits, support Quality team during Certified Body audits for Compliance evidence on products
• Align with Test Labs on requirements, testing scenarios & protocols, and all documented within test plans
• Ability to prepare and review documentation for test labs, notified bodies and other governing regulatory bodies.
• Provide budgetary inputs for compliance testing and certification
• Maintain objective evidence of compliance to applicable regulatory requirements
• Review and critique test reports generated by Test Agencies/Labs
• Work collaboratively with all functions and team members – e.g. program management, field service, manufacturing, electrical, mechanical, compliance and reliability engineers.
• Manage multiple projects and priorities defined by program or functional management.
• Supports CAPA projects and VIP projects, Cost reduction projects, EOL projects, and Operations request for support