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Hologic, Inc. · 3 days ago
Senior R&D Product Compliance Engineer
Newark, DE
Full-time
Onsite
Senior Level
$91K/yr - $143K/yr
5+ years exp
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Responsibilities
Lead and coordinate compliance tasks with internal functions and external test agencies & labs.
Act as a technical advisor and provide guidance to Program Management and Regulatory Assurance.
Participate as a Member of the Project Core Team and drive compliance efforts.
Responsible for reporting status of compliance activities.
Support Marketing & Regulatory’s efforts to identify regulatory compliance requirements.
Work with Marketing, Systems, and Engineering teams to implement requirements into product definitions.
Create Compliance Program Plans.
Oversee EMC, & environmental pre-compliance and compliance testing at Certified Test Labs.
Oversee IEC 60601-1 compliance testing.
Act as the Hologic compliance liaison to Test Labs and Certified Agencies.
Develop EMC & Safety Certification test plans, Verification Procedures and Reports.
Define compliance re-testing needs based on design changes.
Participate in internal failure investigation and design changes during Compliance testing.
Qualification
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Required
Understanding of device product manufacturing and product development & lifecycle processes.
An in-depth understanding of radiated and conducted emissions and susceptibility of systems, able to troubleshoot and will be a key problem solver on projects and must demonstrate a strong commitment to production needs.
Knowledge of EMC design concepts and design practices
Proficient at using laboratory test equipment used in electrical & RF engineering work such as: Multi-meters, Oscilloscopes, Spectrum analyzers, Function generators, Logic Analyzers, environmental chambers
Ability to test and debug medium complexity EMC issues. Subject Matter Experts are available regarding the electrical design details.
Ability to multi-task on multiple projects, provide guidance and interpretation of standards as applied to Hologic products.
Demonstrate logical thinking and mature engineering judgement – ability to debate interpretation of compliance standards.
Experience with compliance testing in a product device field and international certifications.
Experience with wireless technologies including WiFi and RFID.
Experience working with electrical test equipment including spectrum analyzers, vector network analyzers and signal generators is beneficial.
Preferred
College Degree
Technical Bachelor’s Degree
2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD.
Benefits
Comprehensive training
Continued development and training
Competitive salary
Annual bonus scheme
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5,001-10,000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (9)
2022 (26)
2021 (23)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$450M2010-11-30Post Ipo Equity· $450M
1990-03-09IPO· nasdaq:HOLX
1988-01-01Series Unknown· Undisclosed
Leadership Team
Stephen MacMillan
Chairman, President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
Medical Product Outsourcing
2024-05-27
2024-05-25
2024-05-23
Company data provided by crunchbase
