Associate Systems Engineer, Product Development
Inspire Medical Systems, Inc. has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient's outcome is first and foremost our top priority. If you want to be part of a purpose-driven company and directly help to transform lives, this is the perfect opportunity for you! We are recruiting for an Associate Systems Engineer to join our rapidly growing product development team located in the Minneapolis, MN location. As an integral part of our development team, you will work closely with our engineering team to develop software for our next generation Inspire products. MAIN DUTIES/RESPONSIBILITIES o Provide systems expertise for new products as well as changes to existing products with a focus on embedded digital signal processing (DSP) algorithms o Specify, design, implement, verify, validate, debug and support signal processing algorithms, software tools and utilities o Engage in design reviews to ensure designs meet or exceed implementation, testing, scalability, and maintainability best practice guidelines o Support clinical research study planning, development, and execution o Support product risk management activities in compliance with ISO 14971 o Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery o Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations o Support new product launch planning in partnership with operations, marketing, sales & education QUALIFICATIONS Educational Requirements:
Required Bachelor's degree in biomedical, software, computer science, or related field. Preferred Master's degree in biomedical, software, computer science, or related field. Required
Experience:
o Ability to support efficiently specifying, designing, implementing, verifying, validating high quality algorithms o Experience developing algorithms and/or tools in MATLAB, Python, and C+
languages or equivalent o Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership Preferred
Experience:
o 1
years (0
years with Master's degree) of work experience in systems, software or signal processing o Medical device product development experience o Understanding of systems engineering processes o Understanding of embedded signal processing algorithms for physiologic signals o Understanding of embedded software development and testing o Understanding of software and systems considerations for clinical research o Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc. o Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
Salary Range:
$80K -- $100K
Minimum Qualification
Software DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
Required Bachelor's degree in biomedical, software, computer science, or related field. Preferred Master's degree in biomedical, software, computer science, or related field. Required
Experience:
o Ability to support efficiently specifying, designing, implementing, verifying, validating high quality algorithms o Experience developing algorithms and/or tools in MATLAB, Python, and C+
languages or equivalent o Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership Preferred
Experience:
o 1
years (0
years with Master's degree) of work experience in systems, software or signal processing o Medical device product development experience o Understanding of systems engineering processes o Understanding of embedded signal processing algorithms for physiologic signals o Understanding of embedded software development and testing o Understanding of software and systems considerations for clinical research o Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc. o Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
Salary Range:
$80K -- $100K
Minimum Qualification
Software DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
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