Senior Assay Development Engineer

Senior Assay Development Engineer

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.

Our Point of
Care Diagnostics Research & Development department is expanding its
business and is looking for new talents to set up a new R&D dependance at
our production site in Mishawaka, IN, US.

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 Senior Assay Development Engineer to work
together with our multidisciplinary teams developing point-of-care medical
diagnostics solutions. As Assay Development team we are developing and
optimizing assays for disposable cartridges for use in our handheld blood
analysis device that enables near patient blood testing in the acute care
setting. Assays are being developed within the Research and Development
department and the first assay has recently been transferred to our production
site. In the role of Senior Assay Development Engineer in Mishawaka you will
closely collaborate with our R&D site in Eindhoven, the Netherlands. This
collaboration will involve regular visits to the Eindhoven site.

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 around the world. We embrace a
culture of inclusivity in which the power and potential of every individual can
be unleashed. We spark ideas that lead to positive impact and continued
success. Check our Careers Site at (link removed)

Key Responsibilities:




Serve as a liaison between the Research and
Development and the Quality Control and Manufacturing organizations in
Mishawaka. Ensure effective communication across functions on a global basis.
Active support of transfer of new Assays from
R&D to manufacturing.
Support design change activities for
on-market products.
Acquire in-depth knowledge of our assays on
disposable cartridges and related intermediate products.
Apply analytical problem-solving skills to
reagent and system integration issues to identify critical performance factors
for assay development.
Collaborate with key stakeholders to ensure
efficient delivery (on time and within budget) of product development
milestones.
Support on market activities and development
investigations.
Partnering with external partners to support
assay development, verification/validation, and improvement activities
throughout the product lifecycle management process.
Initiate and coordinate continuous improvement
programs to optimize efficiency and minimize variation.
Report progress and deviations to Program
manager and Head of Assay Development.

Required
Education, Experience & Skills

MS or
PhD in Biochemistry, Biophysical/Technology Engineering or equivalent.
At
least 7, preferably 10+ years of experience in Assay development, preferably in
In-Vitro Diagnostics or Medical Device industry.
Experience
with Product Creation and Quality Processes in a regulated industry required to
ensure alignment with regulatory expectations (FDA, IVDR).
Self-motivated
and disciplined to get the job done.
Ability
to communicate clearly and concisely in written and spoken form.
Team-player
with excellent communication and technical skills in multi-disciplinary
environments.
Willing
for regular intercontinental travel.
Pro-active
attitude with a can-do mentality.
Demonstrated
experience in complex experimental and statistical methods.
Proficient
in Microsoft Word, Excel, PowerPoint and familiar with statistical tools such
as Minitab, Analyze-It or JMP.

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.

Beware of Job Scams
Please beware of potentially fraudulent job
postings or suspicious recruiting activity by persons that are currently posing
as Siemens Healthineers recruiters/employees. These scammers may attempt to
collect your confidential personal or financial information. If you are
concerned that an offer of employment with Siemens Healthineers might be a scam
or that the recruiter is not legitimate, please verify by searching for the
posting on the Siemens
Healthineers Career Site.

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.

#LI-EM1



Organization:
Siemens Healthineers

Company:
Siemens Healthcare Diagnostics Inc.

Experience Level:
Experienced Professional

Full / Part time:
Full-time



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