Lead Systems Architect

7 days ago

Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Job Overview

Senior Systems Architect

At Inspire Medical Systems, we are pioneers in the field of neurostimulation technology, dedicated to enhancing the lives of individuals suffering from moderate to severe sleep apnea. As a rapidly expanding organization, our commitment to patient outcomes drives every decision we make. If you are passionate about making a meaningful impact and wish to be part of a mission-oriented team, this opportunity is tailored for you.

Role Summary:

We are seeking a Senior Systems Architect to join our dynamic team. In this position, you will integrate customer requirements, business objectives, and technical knowledge into comprehensive system designs, product development strategies, and implementation plans for the upcoming generation of Inspire products. You will also provide essential technical leadership in therapy and product system design while supporting ongoing engineering efforts as necessary.

Key Responsibilities:

  • Direct new product development initiatives to bring innovative solutions to market and support organizational goals.
  • Deliver system architecture, software, and electrical engineering expertise for both new and existing products.
  • Facilitate product design evaluations for projects in progress and those requiring enhancements.
  • Offer ongoing engineering support for assigned products.
  • Lead and/or assist in product-level risk management processes in alignment with industry standards.
  • Ensure adherence to relevant medical device regulations and standards.
  • Create and validate essential documentation such as design history files, device master records, and engineering change orders.
  • Guarantee compliance with all quality, regulatory, legal, and business requirements throughout the product lifecycle.
  • Assist in post-market product and therapy investigations, including corrective and preventive action (CAPA) activities.
  • Collaborate with contract manufacturers on process validation efforts.
  • Support product launch strategies in collaboration with Marketing, Sales, and Education teams.
  • Document field reports related to products and therapies within specified timelines and provide necessary follow-up as required.
  • Adhere to applicable quality system procedures and policies while suggesting improvements for continuous process enhancement.

Qualifications Required:

  • Bachelor's Degree in Software Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
  • A minimum of 6 years of engineering experience in a regulated environment (e.g., aerospace, healthcare, pharmaceuticals).
  • Proven track record in designing, developing, and delivering embedded software solutions and/or mobile applications.
  • Excellent written and verbal communication skills, capable of engaging with both internal teams and external stakeholders.
  • Proficient in Microsoft Office Suite (Word, Excel, Outlook).

Preferred Qualifications:

  • Advanced degree in Software Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
  • Experience in the development of implantable medical devices.
  • Prior experience in software and/or firmware development, including proficiency in Python, .NET, and/or CAD tools.
  • Familiarity with Agile software development methodologies.
  • Understanding of relevant standards and regulations, including but not limited to:
    • 21 CFR 820
    • IEC 62304
    • Electrical safety testing standards
    • ISO 13485
    • ISO 14971
    • ISO 14708
    • EN 45502
    • ISO/IEC 60601
    • Manufacturing process validation (IQ/OQ/PQ)
  • Knowledge of systems engineering best practices and their application to continuous improvement and usability standards in product development.

Inspire Medical Systems is committed to equal employment opportunities for all employees and applicants, regardless of race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, or any other status protected by law. This policy applies to all aspects of employment, including recruitment, hiring, compensation, promotion, and training.

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