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Lead Systems Engineer

2 months ago

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

Company Overview

At Inspire Medical Systems I, we are a pioneering company dedicated to transforming lives with our innovative neurostimulation technology for moderate to severe sleep apnea.

We are seeking a highly skilled and experienced Senior Systems Engineer to join our team and play a critical role in synthesizing customer needs, business requirements, and technology expertise to design, develop, and implement next-generation Inspire products.

Key Responsibilities
  • Lead Product Development Teams

Lead new product development teams to commercialize innovative products and support business initiatives, ensuring timely and cost-effective delivery of high-quality products.

Provide System Design Expertise

Provide system design, software, and electrical expertise for new products and changes to existing products, ensuring compliance with industry-applicable standards for medical devices.

Lead Product Design Reviews

Lead product design reviews for products in development and continuation, ensuring that all quality system, regulatory, legal, and business requirements are met.

Continuation Engineering Support

Provide continuation engineering support for products as assigned, ensuring that all quality system, regulatory, legal, and business requirements are met.

Lead Risk Management Activities

Lead and/or support product-level risk management activities in compliance with ISO 14971, ensuring that all quality system, regulatory, legal, and business requirements are met.

Ensure Compliance

Ensure compliance with industry-applicable standards for medical devices, including generating and approving design history file documents, device master record documents, and engineering change order records.

Support Post-Market Activities

Support post-market product and/or therapy-related investigations, CAPA activities, and implementations, ensuring that all quality system, regulatory, legal, and business requirements are met.

Work with Contract Manufacturers

Work with contract manufacturers on process validation activities (IQ/OQ/PQ), ensuring that all quality system, regulatory, legal, and business requirements are met.

Support New Product Launch Planning

Support new product launch planning in partnership with Marketing, Sales & Education, ensuring that all quality system, regulatory, legal, and business requirements are met.

Document Field Reports

Document product and therapy-related field reports within prescribed timelines and provide necessary documents for investigation, ensuring that all quality system, regulatory, legal, and business requirements are met.

Comply with Quality System Procedures

Comply with applicable quality system procedures/policies and suggest continuous process improvements, ensuring that all quality system, regulatory, legal, and business requirements are met.

Requirements
  • Education

Bachelor's Degree in Software, Electrical Engineering, Biomedical, or a related discipline.

Experience

6+ years of engineering experience from a regulated industry (aerospace, healthcare, pharmaceuticals, etc.).

Skills

Demonstrated experience designing, developing, and delivering embedded software technology and/or mobile applications, strong written and verbal communication skills, and proficiency with MS Suite (Word, Excel, Outlook).

Preferred Qualifications
  • Advanced Degree

Advanced level degree in Software, Electrical Engineering, Biomedical, or related discipline.

Experience with Implantable Medical Products

Experience with implantable medical product development.

Software Development Experience

Previous software and/or firmware development experience, including Python,.NET, and/or CAD software.

Agile Software Development Experience

Agile software development experience.

Industry Standards and Regulations

Demonstrated understanding of relevant industry standards and regulations.

About Inspire Medical Systems I

We are an equal opportunity employer committed to diversity and inclusion, striving to create a workplace where everyone feels valued, respected, and empowered to contribute their best work.

We are dedicated to transforming lives with our innovative neurostimulation technology and are seeking talented individuals to join our team.