Senior R&D Engineer, Clinical
Company: Abbott Laboratories
Posted on: June 4, 2021
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals, and branded generic medicines. Our 109,000 colleagues
serve people in more than 160 countries.
Our Neuromodulation business is an area of expertise for Abbott.
This business includes implantable devices compatible with mobile
technology to help people who suffer from chronic pain and movement
disorders. Our Solutions include Proclaim (TM) XR SCS System, the
#1 Spinal cord stimulator on the market, Proclaim (TM) DRG
Neurostimulator, the only FDA approved DRG therapy and a market
leader in radiofrequency ablation therapy, Abbott RFA. These
non-opioid therapies allow us to provide interventional pain
therapy to patients throughout the pain continuum. Our deep brain
stimulation technology for progressive diseases help people manage
their Parkinson's disease and essential tremor symptoms, steering
away from side effects.
Our location in Plano, TX currently has an opportunity within
R&D for a Senior Clinical Engineer. The Clinical Engineer uses
in-depth knowledge of anatomy and biomechanics to work with design
engineers and clinicians to develop safe and highly effective new
products and upgrades to existing products for our neuromodulation
systems platform. The Engineer is responsible for establishing
data-driven customer requirements, validating customer requirements
to ensure a high-quality patient outcome, and conveying the
clinical value throughout the organization, including demonstrating
that products meet their intended use within their use environment.
The Clinical Engineer is also responsible for leading risk
assessment activities as well as usability initiatives across
WHAT YOU'LL DO
Develop Customer Requirements Documents and support development
of System Requirements Documents and Product Requirement
Assess and document clinical design risks and advise the team on
risks and mitigations.
Develop, plan, execute, analyze and document experiments, and
draw relevant conclusions.
Develop Design Validation Plans, Protocols & Reports. Conduct
preclinical validations and design iteration assessments of
products both internally and with external key opinion leaders.
Conduct formal validation testing for new products, product
updates, and modifications to existing designs, to ensure the
clinical safety and efficacy of the product.
Develop/modify clinical workflows and facilitate the transition
of new/updated technology and features into products through
clinical review and evaluation.
Leverage clinical and product expertise to aid new concept and
product development and evaluate compatibility of system components
in clinical workflow scenarios.
Plan and conduct worldwide customer, competitive, and software
industry research to identify and prioritize usability improvement
possibilities and solutions.
Organize and manage work to deliver usability deliverables on
Prioritize tasks by distinguishing urgent from important tasks
and assesses cost/benefit trade-offs.
Develop understanding of the scientific, technical, medical, and
clinical aspects of Abbott neuromodulation devices and features and
the disease states they aim to treat.
Support clinical evaluation of new or enhanced products.
Identify potential product enhancements and new product ideas by
applying an analytical approach to understanding the clinical needs
Maintain a detailed understanding of the developing clinical
environment (e.g. current treatment methods, evolving clinical
- Maintain a detailed understanding of Abbott, FDA 21 CFR Part
820, and ISO regulations.
EDUCATION AND EXPERIENCE YOU'LL BRING
Bachelor's degree in Biomedical Engineering/Mechanical
Engineering/Electrical Engineering/related engineering field or an
equivalent combination of education and experience.
Minimum 6 years relevant, progressively more responsible work
experience in medical product development and/or a graduate degree
with relevant project experience.
- Demonstrated ability to apply an expert understanding of
clinical application to issues in order to bring tasks to
resolution within assigned projects. Demonstrated ability to
effectively integrate information from varied disciplines
including Clinical Medicine, Engineering, Marketing and Regulatory
Self-starter needing minimal supervision. Strong verbal and
written communications with the ability to effectively communicate
at multiple levels within the organization.
Experience interfacing with a variety of management levels and
effectively presenting technical information.
- Ability to work in a highly matrixed and geographically diverse
business environment. Ability to work within a team and as an
individual contributor in a fast-paced, changing
environment. Ability to leverage and/or engage others to
accomplish projects. Multitasks, prioritizes and meets deadlines in
timely manner. Strong organizational and follow-up skills, as well
as attention to detail.
Experience gathering user needs and defining customer
Experience generating data-driven justifications for
requirements, including designing and executing testing needed to
support clinical justifications.
Experience working on teams to design devices that meet user
Experience designing and leading preclinical device studies.
Experience leading technical reviews.
Experience working with physicians in a clinical environment
(OR, ASC, in-office).
Advanced credentials in a relevant discipline/concentration,
including Biomedical Engineering or medical field.
Experience with Matlab, Simulink, or equivalent.
Fluent in surgical terminology and sound knowledge of anatomy
and surgical techniques.
Technical or medical experience in neuromodulation.
Technical or medical experience with Spinal Anatomy.
Experience supporting physician visits.
- Experience supporting clinical testing of devices.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great
career. We offer:
Training and career development, with onboarding programs for
new employees and tuition assistance
Financial security through competitive compensation, incentives
and retirement plans
Health care and well-being programs including medical, dental,
vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial
performance and history of being actively involved in local
Learn more about our benefits that add real value to your life
to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse
opportunities with a company that provides the growth and strength
to build your future. Abbott is an Equal Opportunity Employer,
committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
Keywords: Abbott Laboratories, Plano , Senior R&D Engineer, Clinical, Other , Plano, Texas
Didn't find what you're looking for? Search again!