Standards & Technical Regulations Manager

Do you want to join us in
helping to fight the worlds 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 whats possible in healthcare to help
improve peoples 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 whats
possible, to improve peoples lives We spark ideas that lead to positive impact
and continued success. Check our Careers Site at (link removed)

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 ifyou 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 Bachelors 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 (link removed)

If
you wish to find out more about the specific before applying, please visit: (link removed)

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



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