Job Information
Hologic Lead R&D Product Compliance Engineer in Newark, Delaware
Lead R&D Product Compliance Engineer
Newark, DE, United States
Hologic is seeking a Lead Compliance Engineer, R&D, Central Engineering to join our Breast and Skeletal Health Division at our expanding Innovation Center located in Newark, DE.
The Lead Compliance Engineer will be responsible for leading product design reviews, identifying and interpreting applicable regulatory standards and requirements; provides guidance and training to prevent compliance issues from the initial product design throughout production and delivery of the final product.. The Senior Compliance Engineer having wide-ranging experience, will use professional concepts and company objectives to resolve complex issues in creative and effective ways. 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 R&D 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 R&D 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:
Thorough understanding of medical device compliance and safety standards.
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 complex EMC issues and develop.
Ability to lead 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.
Strong interpersonal, communication, analytical and complex problem-solving skills.
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.
Proficiency in revision control for design and documentation.
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.
Familiarity with Risk Assessment Management.
Proficiency in Word Office Suite a must – Excel, Word, PowerPoint.
Ability to mentor and train junior engineers is beneficial.
Qualifications:
Education
Preferred Minimum Non-Technical Degree: College Degree
Preferred Minimum Technical/Advanced Degree: Master’s Degree
Experience
Preferred Minimum Non-Technical Degree: 8+ Years
Preferred Minimum Technical/Advanced Degree: 6+ Years with Master’s Degree, 3+ Years with PhD
Experience with compliance testing in a product device field and international certifications.
Experience with wireless technologies including Wi-Fi and RFID
Experience working with electrical test equipment including spectrum analyzers, vector network analyzers and signal generators is beneficial. \
Experience leading cross functional teams and projects 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 $111,400 - $174,300 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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