Principal Software Design Assurance Engineer

Inspire Medical Systems; Golden Valley (MN); On-site; USD 130,000 - 196,000; Full time

Job summary

A leading medical device company is seeking a Principal Software Design Assurance Engineer to ensure product software quality assurance for innovative medical devices. This role involves collaboration across various departments to meet regulatory compliance and quality objectives. The ideal candidate will have extensive experience in medical device software quality and a commitment to enhancing patient outcomes.

Benefits

401k matching

Flexible time off

Tuition reimbursement

Health insurance options

Employee Stock Purchase Program

Qualifications

• 12 years minimum experience in medical device software quality.
• Comprehensive knowledge of medical software design standards.
• Experience with risk management standards like ISO14971.

Responsibilities

• Ensure design control requirements are implemented and followed.
• Partner with Development to generate project deliverables.
• Lead risk management activities from product concept through commercialization.

Skills

Leadership

Project Management

Time Management

Education

Bachelor's degree in a technical or scientific field

Tools

JIRA

MS Word

Excel

PowerPoint

Job description

Principal Software Design Assurance Engineer

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Principal Software Design Assurance Engineer

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About Inspire Medical Systems

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

About Inspire Medical Systems

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!

Essential Job Functions

This position is responsible for product software quality assurance support of new product development projects and design changes. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects with a primary focus on software projects. This individual will ensure that the quality objectives are met during the product development and design transfer life cycle. This individual will also be responsible for assessing manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.

This position is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance and provide technical direction to Inspire staff on matters of quality and compliance throughout the product’s lifecycle. This position will work with Development, Operations, Manufacturing, Regulatory, Quality and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Partner with Development to generate project deliverables and conduct audits of the deliverables prior to product release.
• Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicating & resolving gaps with cross-functional team members.
• Provide product software design assurance services, including planning for software design validation, design transfer, test system development and validation., Including active cross-functional root-cause analysis investigation and resolution.
• Partner with Development on the validation of software test environments and software tools, including test methodology, test protocol and acceptance criteria development.
• Lead risk management activities from product concept through commercialization.
• Product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards. Lead and document standard updates and compliance reviews at the prescribed frequency.
• Provide quality engineering support for design changes, sustaining engineering projects and when applicable supplier changes.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Ensure quality system procedural requirements and development life cycle phases are followed.
• Ensure proper cyber security testing and controls are utilized and documented
• Generate and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Software Design Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support both internal and external audit activities.
• Support other quality projects and initiatives as assigned.
  
  

Required

WHAT YOU CAN BRING TO OUR GREAT TEAM

• Bachelor’s degree in a technical or scientific field
• 12 years minimum experience a medical device software quality or software design assurance role for finished medical devices.
• Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design.
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects A Knowledge on medical device data systems (MDDS)
• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
• Knowledge on ISO and FDA/Quality System Requirements. (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822)
• Experience working with HIPPA and GDPR.
• Strong project and time management skills
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint
• Experience with Class III active implantable products.
  
  

Preferred

• Experience in software design reliability, process and product quality assurance functions
• ASQ certifications; CSQE, CRE, CQM, CQE, etc.
• Experience working with bug tracking tools such as JIRA.
• Experience with GHTF requirements for process validations, etc
  
  

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

Salary

$130,400—$195,600 USD

Benefits And Other Compensation

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
  
  

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is anequal opportunityemployer with recruitment efforts focused on ensuring a diverse workforce.Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com

Inspire Medical Systems participates in E-Verify.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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