Inspire Medical Systems
Systems Engineering Manager
Inspire Medical Systems, Golden Valley, Minnesota, United States,
Systems Engineering Manager – Minneapolis, MN
ABOUT INSPIRE MEDICAL SYSTEMSInspire 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 TEAMAt 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 FUNCTIONSWe are recruiting a Systems Engineering Manager to join our team. In this role, you will focus on leading a team of 5-10 engineers who are directly involved in product development efforts of our implantable and external products. You will be responsible for synthesizing customer and business needs, and providing technical expertise into product development and implementation plans for the next generation of Inspire products.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLELead the definition and implementation of functional excellence initiatives across the organizationIdentify efficiencies in processes and streamline workflowsWork with cross functional stakeholders to set priority and identify critical pathsInterface with software development partners to support new product developmentInterface with operations and external manufacturing partners to support new product development and commercially released productsLead and/or support product level risk management activities in compliance with ISO 14971Assure compliance with industry applicable standards for medical devicesEnsure all quality system, regulatory, legal, and business requirements are met in the course of product development and market deliverySupport post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.Support new product launch planning in partnership with Operations, Marketing, Sales & EducationGenerate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
WHAT YOU CAN BRING TO OUR GREAT TEAMRequired:Bachelor’s degree in engineering or related field6+ years of product development experience for innovative medical devices1+ year of building, managing, and leading high-performing product development teamsExperience as primary point of contact for external design / test / manufacturing vendorsUnderstanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development, and manufacturingPreferred:Master’s degree in engineering or related fieldExperience as technical leader on product development teams consisting of internal and contract resourcesExtensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
BENEFITS AND OTHER COMPENSATIONInspire offers a highly competitive benefits package including: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 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 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(dot)com.
Inspire Medical Systems participates in E-Verify.
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ABOUT INSPIRE MEDICAL SYSTEMSInspire 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 TEAMAt 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 FUNCTIONSWe are recruiting a Systems Engineering Manager to join our team. In this role, you will focus on leading a team of 5-10 engineers who are directly involved in product development efforts of our implantable and external products. You will be responsible for synthesizing customer and business needs, and providing technical expertise into product development and implementation plans for the next generation of Inspire products.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLELead the definition and implementation of functional excellence initiatives across the organizationIdentify efficiencies in processes and streamline workflowsWork with cross functional stakeholders to set priority and identify critical pathsInterface with software development partners to support new product developmentInterface with operations and external manufacturing partners to support new product development and commercially released productsLead and/or support product level risk management activities in compliance with ISO 14971Assure compliance with industry applicable standards for medical devicesEnsure all quality system, regulatory, legal, and business requirements are met in the course of product development and market deliverySupport post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.Support new product launch planning in partnership with Operations, Marketing, Sales & EducationGenerate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
WHAT YOU CAN BRING TO OUR GREAT TEAMRequired:Bachelor’s degree in engineering or related field6+ years of product development experience for innovative medical devices1+ year of building, managing, and leading high-performing product development teamsExperience as primary point of contact for external design / test / manufacturing vendorsUnderstanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development, and manufacturingPreferred:Master’s degree in engineering or related fieldExperience as technical leader on product development teams consisting of internal and contract resourcesExtensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
BENEFITS AND OTHER COMPENSATIONInspire offers a highly competitive benefits package including: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 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 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(dot)com.
Inspire Medical Systems participates in E-Verify.
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