Inspire Medical Systems
Principal Software Design Assurance Engineer
Inspire Medical Systems, Minneapolis, Minnesota, United States, 55400
Principal Design Assurance Engineer – Inspire Medical Systems
2 days ago – Be among the first 25 applicants.
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.
Essential Job Functions
Support product software quality assurance of new product development projects and design changes.
Ensure design control requirements are implemented and followed; support multiple product development projects with a primary focus on software projects.
Ensure the quality objectives are met during the product development and design transfer life cycle.
Assess manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.
Perform tasks that assure a high level of product reliability along with regulatory compliance and provide technical direction on quality and compliance throughout the product’s lifecycle.
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 & Responsibilities
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 communicate & resolve 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.
Provide 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 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.
Provide project direction, coaching, and mentoring for engineering and technical team personnel to ensure best‑in‑class software design quality engineering practices.
Apply 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 Qualifications
Bachelor’s degree in a technical or scientific field.
12 years minimum experience in a medical device software quality or software design assurance role for finished medical devices.
Comprehensive knowledge of 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.
Knowledge of medical device data systems (MDDS).
Experience with risk management standard ISO14971 and risk management tools such as dFMEA and pFMEA.
Knowledge of ISO and FDA/Quality System Requirements (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822).
Experience working with HIPAA and GDPR.
Strong project and time‑management skills.
Ability to work on multiple tasks concurrently with changing priorities.
Proficiency with MS Word, Excel and PowerPoint.
Experience with Class III active implantable products.
Preferred Qualifications
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.
Salary $130,000—$190,000 USD
Benefits
Multiple health insurance plan options.
Employer contributions to Health Savings Account.
Dental, Vision, Life and Disability benefits.
401(k) plan with employer match.
Identity Protection.
Flexible time off.
Tuition reimbursement.
Employee Assistance program.
Equity awards and Employee Stock Purchase Program participation.
Equal Employment Opportunity Statement 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 an equal opportunity employer 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.com. Inspire Medical Systems participates in E‑Verify.
#J-18808-Ljbffr
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.
Essential Job Functions
Support product software quality assurance of new product development projects and design changes.
Ensure design control requirements are implemented and followed; support multiple product development projects with a primary focus on software projects.
Ensure the quality objectives are met during the product development and design transfer life cycle.
Assess manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.
Perform tasks that assure a high level of product reliability along with regulatory compliance and provide technical direction on quality and compliance throughout the product’s lifecycle.
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 & Responsibilities
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 communicate & resolve 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.
Provide 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 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.
Provide project direction, coaching, and mentoring for engineering and technical team personnel to ensure best‑in‑class software design quality engineering practices.
Apply 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 Qualifications
Bachelor’s degree in a technical or scientific field.
12 years minimum experience in a medical device software quality or software design assurance role for finished medical devices.
Comprehensive knowledge of 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.
Knowledge of medical device data systems (MDDS).
Experience with risk management standard ISO14971 and risk management tools such as dFMEA and pFMEA.
Knowledge of ISO and FDA/Quality System Requirements (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822).
Experience working with HIPAA and GDPR.
Strong project and time‑management skills.
Ability to work on multiple tasks concurrently with changing priorities.
Proficiency with MS Word, Excel and PowerPoint.
Experience with Class III active implantable products.
Preferred Qualifications
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.
Salary $130,000—$190,000 USD
Benefits
Multiple health insurance plan options.
Employer contributions to Health Savings Account.
Dental, Vision, Life and Disability benefits.
401(k) plan with employer match.
Identity Protection.
Flexible time off.
Tuition reimbursement.
Employee Assistance program.
Equity awards and Employee Stock Purchase Program participation.
Equal Employment Opportunity Statement 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 an equal opportunity employer 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.com. Inspire Medical Systems participates in E‑Verify.
#J-18808-Ljbffr