Senior Compliance Engineer
Hologic Breast and Skeletal Health Division has an exciting opportunity for an experienced Sr. Compliance Engineer.
In this role you will have the opportunity to:
- Ensure Hologic medical products meet all applicable EMC/EMI and safety compliance standards for our global markets throughout the product lifecycle – including design for compliance, certification, and global regulatory compliance – such as EU MDR.
- Collaborate with R&D engineers, Regulatory Assurance, and Design Assurance, as well as with external Test Labs such as UL, CSA, or Certified Agencies.
- 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.
- Provide time critical solutions to our customers, and navigate across functions and business operations to influence positive outcomes.
- May supervise the activities of others and will often provide guidance to Program Management, Regulatory Assurance, and R&D staff.
What we expect:
- 6+ years of experience in compliance testing and international certifications.
- 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
- Experience with wireless technologies including WiFi and RFID
- Must be a self-starter, motivated and able to work independently with minimum supervision
- Strong interpersonal, communication, analytical and complex problem-solving skills.
- The ability to develop partnerships with cross-functional teams across company sites.
- Ability to work in fast paced environment with a sense of urgency of tasks.
- Ability to collaborate effectively in cross functionally teams, with technical and non-technical colleagues
- Understands device product manufacturing and product development & lifecycle processes
- Familiarity with Risk Assessment Management
- Understanding of medical device compliance and safety standards a plus.
- Proficient at using laboratory test equipment used in electrical & RF engineering work. This includes most of the following:
- Multi-meters, Oscilloscopes, Spectrum analyzers, Function generators, Logic Analyzers, environmental chambers
- Proficiency in revision control for design and documentation a must
- Proficiency in at least one software language a must - e.g. Python
- Familiar with government-regulated and/or certified engineering environments (FDA, FAA, DoD, ISO, etc…).
- Proficiency in Word Office Suite a must – Excel, Word, PowerPoint
Skills/Specialized Knowledge
- Must be able to test and debug medium complexity EMC issues. Subject Matter Experts are available regarding the electrical design details
- Must be able to multi-task on multiple projects, provide guidance and interpretation of standards as applied to Hologic products
- Demonstrates logical thinking and mature engineering judgement – ability to debate interpretation of compliance standards
Education
- Bachelor's Degree in Electrical, RF Engineering, or equivalent
Experience
- Minimum of 6 years’ relevant Compliance Test experience in a product device field – medical preferred.
Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-LL1