Senior Compliance Engineer

Newark, DE, United States

Hologic is seeking a Senior Compliance Engineer, RD, Central Engineering to join our Breast and Skeletal Health Division at our expanding Innovation Center located in Newark, DE.

The Senior Compliance Engineer will be responsible for defining and executing product compliance strategies, policies, and processes to ensure that the company’s products meet regulatory standards and compliance certifications are obtained and maintained for global markets (e.g., ISO, FCC, UL, IEEE). The Senior Compliance Engineer will work closely with regulatory agencies and is the technical subject matter expert for regulatory compliance. Apply today!

What to Expect:

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.

Acts as a technical advisor and provides guidance to Program Management, Regulatory Assurance, and other RD functions.

Participate as a Member of the Project Core Team and drive compliance efforts.

Responsible for reporting status of compliance activities.

Supports Marketing Regulatory’s efforts to identify applicable regulatory compliance requirements and provide technical translation of requirements to RD teams.

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 – e.g. UL, CSA, TUV, BSI.

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 where they arise during Compliance testing.

What We Expect:

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.

Qualifications:

Education

Preferred Minimum Non-Technical Degree: College Degree

Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree

Experience

Preferred Minimum Non-Technical Degree: 5-8 Years

Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD.

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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $91,200 - $142,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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.

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