Senior Hardware Systems Engineer - New Product Development
Company: Avanos Medical
Posted on: April 3, 2021
The roleThe purpose of the Senior Systems Hardware Engineer is
to support the full development lifecycle of new products from
concept through product realization and the implementation of
changes to legacy products, primarily embedded medical devices
containing custom and off-the-shelf hardware and software
components and having related disposables. This position reports to
a Senior Manager or Associate Director of Global R&D for Avanos
Medical Inc. As an individual contributor and/or a core team
technical leader on a multi-disciplinary engineering team, this
position applies their specialized skill set, a deep working
knowledge of scientific principles, and a passion for product
development in overseeing the full product lifecycle for
electronic/electromechanical/mechanical medical devices. He/she
acts as a technical expert and systems engineering focused leader
in developing new devices that integrate innovative technologies
aiming to improve or establish new standards of care and in
addressing the essential business support activities for legacy
devices. This individual will be responsible for the design,
development, & implementation of new products and
changes/improvements to existing products. This individual will
plan, lead, and execute technical and cross-functional project work
in various phases of medical device product development, including
but not limited to research, technical feasibility studies, design
and development planning, requirements definition, architectural
definition, product design and development, root cause analysis,
risk assessment, test method development, design
verification/validation, and design transfer. Essential Duties and
- Collect and analyze design inputs (customer needs, business
needs, etc.) and transform them into high-quality engineering
- Analyses are performed at all levels of total system product to
include: concept, design, fabrication, test, installation,
operation, maintenance and disposal.
- Ensures the logical and systematic conversion of product
requirements into total system solutions that acknowledge
technical, schedule, and cost constraints.
- Collaborate with project managers in scoping of all engineering
- Drive definition of regulatory requirements related to country
specific standards, packaging standards, and internal constraints
from the business.
- Apply a working knowledge of scientific principles in designing
& developing both products & process for manufacturability &
- Performs functional analysis, timeline analysis, detailed trade
studies, requirements allocation, and interface definition studies
to translate customer requirements into hardware and software
- Lead, coordinate, execute, and document system analysis and
design activities including but not limited to architecture
definition, interface management, performance modeling,
traceability, and system integration, etc.
- Verify system requirements have been properly implemented
(writing, leveling, tracing) through inspection, demonstration,
test or analysis.
- Validate that implemented systems meet customer needs
- Research & evaluate manufacturing methods to inform technical
- Ensure product designs meet required standards for medical
- Design & conduct feasibility test methods to confirm
- Lead the preparation, execution, & documentation of technical
- Develop high quality technical specifications for products.
Your qualifications Required
- BS in Electrical Engineering, Electronics Engineering, Systems
Engineering, or similar discipline with 7+ years of relevant
- MS in Engineering with 5+ years of relevant experience OR
- PhD in Engineering with 3+ years of relevant experience.
- Deep working knowledge of medical device design control
processes & related standards, including but not limited to
IEC-60601, ISO-13485, ISO-14971.
- Advanced understanding of engineering statistical tools/methods
such as DOE, Monte Carlo, Minitab, ANOVA
- Detail-oriented with strong organizational, problem solving,
and communication skills (both written and oral).
- Superior computer skills, with solid experience in Minitab,
and/or Matlab/LabView programs.
- Able to communicate complex results, risks, & options in an
effective manner conducive to aid the decision-making process.
- Degree in Electrical Engineering with working knowledge in the
principles of analog electronics with embedded digital
- Previous medical device experience with a history of developing
products from technology to market release
- DFSS Black Belt certification
- Experience developing hardware and/or software applications for
- Experience developing system definition, system design and
requirements, requirement tracing to subsystems and interface
requirements, and system verification and validation strategy and
- Experience with systems engineering principles, including
requirement analysis and allocation, architecture, verification,
- Demonstrated commitment to continuous improvement by studying
and applying technical advances in area of expertise
- Demonstrates experience in executing product changes regulated
by design control.
- Experience in all phases of the Product Management Life Cycle,
- Experience in the design, development, & manufacturing of
peripheral & disposable devices that work in conjunction with
electronic medical devices.
- Understanding how design decisions impact regulatory path.
- Familiarity with requirement management tools such as
Keywords: Avanos Medical, Alpharetta , Senior Hardware Systems Engineer - New Product Development, Other , Alpharetta, Georgia
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