Software Engineer - Medical Device Software

Description

The company makes an FDA-approved medical device that reduces the severity of obstructive sleep apnea (OSA) for people who cannot tolerate CPAP or do not get consistent benefit from it.

The software engineer joins the Digital Solutions team in Minneapolis, MN, working alongside engineers and scientists to build applications for the company's next generation of products.

Responsibilities

• Build and deploy patient management and support services on Azure using.NET Core, C, Python, and/or other supporting languages.
• Help prepare system, software, security, and risk management documents.
• Test, debug, and document integration solutions, and improve existing components so software meets business needs while complying with regulations and processes such as IEC 62304.
• Make sure the software meets applicable medical device standards.
• Confirm that quality system, regulatory, legal, and business requirements are met throughout product development and delivery to market.
• Create, control, and store software source and executable code. Support customers as assigned.
• Write and approve design history file documents, device master record documents, engineering change orders, and other quality system records as assigned.
• Develop and disclose new technology and solutions, and support the patent process for them.
• Document product and therapy field reports within required timelines, supply documents needed for investigations, and file follow-up reports when needed.
• Complete required training and competency confirmations on schedule.
• Follow quality system procedures and policies, and suggest ways to improve processes.

Requirements

• A bachelor's degree in engineering, software, computer science, or a related discipline.
• 2-4 years of.NET development experience in C or a similar object-oriented language.
• Experience with Azure deployment tools and build processes for downloadable software.
• Familiarity with software as a medical device (SaMD) regulations, such as IEC 62304, IEC 82304-1, and ISO 13485.
• Familiarity with verification best practices for FDA-regulated software.
• Strong written and verbal communication skills, with the ability to work with internal and external stakeholders and senior department leaders.
• Preferred: an advanced degree in engineering, software, computer science, or a related discipline.
• Preferred: experience on Agile development teams and their practices.
• Preferred: experience reviewing peers' code on a collaborative development team.
• Preferred: experience with the medical device development cycle.
• Preferred: experience authoring QMS and FDA-regulated software documentation.

Conditions

Onsite position.

Salary range: $90,000 - $120,000 USD. Final pay depends on factors such as location, experience, education, and skill level, and may change over time.

The company provides equal opportunity in employment. Applicants who need accommodation during the application process can contact Human Resources.

Benefits

• Multiple health insurance plan options and employer contributions to a Health Savings Account.
• Dental, vision, life, and disability coverage.
• 401k plan with employer match, plus an Employee Stock Purchase Plan.
• Flexible time off and tuition reimbursement.
• Identity protection and an employee assistance program.
• Employees at all levels can take part in company ownership through equity awards and the stock purchase program.
• A people-first culture with a focus on learning and building a professional network.