Über diese Sr. Systems Engineer Stelle bei Inspire Medical Systems Inc.
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 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!
We are recruiting for a Senior Systems Engineer to join our growing product development team located in the Minneapolis, MN location. As an integral part of our development team, you will work closely with our engineering team to develop software for our next generation Inspire products.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
- Partners with Marketing, Clinical, Human Factors, Medical Safety, and field-facing teams to translate stakeholder needs, use cases, and use environments into clear system-level design inputs.
- Responsible for defining, evaluating, and maintaining system design, functional decomposition, interfaces, operating modes, performance budgets, and key design trade-offs across hardware, software, firmware, disposables, and accessories.
- Responsible for the development, review, requirement allocation, and lifecycle management of stakeholder needs, system and product requirements, particularly interface and performance requirements, ensuring clarity, testability, consistency, and end-to-end traceability.
- Contribute to or lead design and technical reviews to ensure designs meet or exceed design inputs and follow best practices for testing, scalability, and maintainability.
- Support and create product risk management (DFMEA and UFMEA) deliverables in compliance with ISO 14971, specifically providing technical input on system level effects.
- Support design transfer activities to ensure the design has been properly transferred to manufacturing
- Support new product launch planning in partnership within product development, operations, marketing, sales & education
- Supports monitoring product performance, complaint investigations, and supports evaluation of quality issues impacting released product
- Supports technical problem solving including CAPA investigations and triaging issues.
- Demonstrates the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.
WHAT YOU CAN BRING TO OUR GREAT TEAM
Required:
- 5+ years (3+ years with Master’s degree) of work experience in systems, software or signal processing
- Ability to efficiently specify, design, implement, verify, validate, and support high quality design features
- Ability to perform statistical analysis (e.g. distribution identification, capability analysis, statistical comparisons)
- Experience developing tools in MATLAB, Python, and C++ languages or equivalent
- Bachelor’s degree in biomedical, software, computer science, or related field.
- Medical device product development experience
- Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc.
- Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
Preferred:
- Understanding of systems engineering processes and practices
- Understanding of mechanical, electrical and embedded signal processing algorithms for physiologic signals
- Understanding of software and systems considerations for clinical research
- Master’s degree in biomedical, software, computer science, or related field.
#LI-Onsite
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.
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 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.
