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Standards & Technical Regulations Manager

Job Description

 

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Standards and Technical Regulations Manager to manage, develop and grow the technical skills and competencies of the EMC & Safety Testing Team.

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

 

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Standards and Technical Regulations Manager you will be responsible for:

Working closely with the Systems, Design Engineering and Product Management functions to achieve product conformity of our new product designs. Provide conformity assessments and consultation services, navigating dynamic international regulations, obtaining required approvals, accreditations, and necessary documentation to bring products to the global markets. 

Lead and technical team at our “state of the art” facility located in Flanders NJ, leverage your experience to execute the following:

  • Proactively collaborate with staff from Engineering, Regulatory & Quality Management during all stages of the product development life cycle to ensure compliance with the EMC & Safety Standards to the latest European & FDA Regulatory Guidance Documents.
  • Apply “state of the art” Requirements in least burdensome fashion, maintaining user workflow and functionality.
  • Ensure commercialized manufactured devices remain in compliance with the newly released standards.
  • Maintain our accredited “user friendly” ISO 17025 EMC & Safety lab.
  • Prepare concise and detailed test plans and test reports working within the project timelines

This position may suit you best if you are familiar with what is below, would like to do develop your career with Healthineers.

  • You have good PC skills (MS Office software like Word, PowerPoint, Excel, and Outlook)
  • You will be working with our latest technology and therefore you are willing to learn about new software and hardware solutions as well as operating various Diagnostic Instruments.
  • You must have very good communication skills, show team orientation and be proactive in performance of assigned tasks.
  • Ability to read and understand schematics, wiring diagrams and mechanical assembly drawings.
  • You will be working with our latest technology and therefore you are willing to learn about new software and hardware solutions
  • Willingness to travel between our R&D sites and partner testing laboratories.

Required skills to have for the success of this role

  • This position requires a minimum of a Bachelor’s degree in an engineering discipline.
  • Able to provide technical regulatory compliance services encompassing consultation, research, methodology, planning, testing, record management for Product Safety, EMC, Machinery, Wireless, IVD and others. Principal standards include but not limited to IEC/EN/UL 61010-1,     IEC 61010-2-x, IEC 61326-2-6, FCC Part 15, EU Directives IVDR, IECEE CB Scheme certificates.
  • Lead team that is responsible to perform EMC and product safety pre-testing, coordination with testing labs, compliance verification, trouble shooting, report writing, and review of all ECO's.
  • Lead team that is responsible to perform Environmental and Altitude testing.

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date, except where prohibited by state law.  Accommodations may be requested for certain medical or religious reasons.  If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer.  Details on how to submit approval will be provided by your recruiter.  An accommodation approval must be confirmed prior to your start date.  A start date cannot be confirmed until the accommodation has been reviewed.  An accommodation is based on your role.  If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Full / Part time: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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