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Senior Hardware Systems Engineer - New Product Development (2926)

Company: Avanos Medical, Inc.
Location: alpharetta
Posted on: May 3, 2021

Job Description:

Requisition ID: 2926

Job Title: Senior Hardware Systems Engineer - New Product Development

Job Country: United States (US)

Here at Avanos Medical, we passionately believe in three things:

* Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; * Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; * Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com.

The role

The 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 Responsibilities

* Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high-quality engineering requirements. * 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 efforts required * 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 & overall reliability. * Performs functional analysis, timeline analysis, detailed trade studies, requirements allocation, and interface definition studies to translate customer requirements into hardware and software specifications. * 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 specifications. * Ensure product designs meet required standards for medical devices. * Design & conduct feasibility test methods to confirm capabilities. * Lead the preparation, execution, & documentation of technical design reviews. * 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 experience OR * 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.

Preferred:

* Degree in Electrical Engineering with working knowledge in the principles of analog electronics with embedded digital experience. * 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 electronic devices * Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing * Experience with systems engineering principles, including requirement analysis and allocation, architecture, verification, and validation * 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, including feasibility. * 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 JAMA.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here .

Join us at Avanos

Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count

Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

free onsite gym | onsite cafeteria | benefits on day 1 | uncapped sales commissions | HQ region voted 'best place to live' by USA Today

Keywords: Avanos Medical, Inc., Alpharetta , Senior Hardware Systems Engineer - New Product Development (2926), Other , alpharetta, Georgia

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