Product Manager, Programming Software 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 We are recruiting for a Product Manager, Programming Software to join our team. In this newly created role, you will drive the strategy and roadmap, and execution of Inspire's programming software. You will lead the creation of a customer-centric roadmap, working closely with the Product Owner and Agile teams to ensure alignment with regulatory requirements, business objectives, and user needs. This role requires a strong blend of technical acumen, strategic thinking, and stakeholder management within the med device industry. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE Product Management
- Define and drive the product vision, strategy, and roadmap for Inspire's programming software in alignment with business objectives and customer needs.
- Prioritize features and enhancements with the product team that meet customer expectations and business objectives.
- Communicate product strategy, milestones, and progress to key stakeholders.
- Partner with regulatory affairs, clinical, legal, and quality assurance teams to navigate the complexities of developing a digital medical device product.
- Act as the bridge between technical teams and business stakeholders to translate business requirements and customer needs into technical solutions.
- Manage cross-functional teams, ensuring alignment between stakeholders.
- Leverage data insights and analytics to refine the product roadmap and drive innovation.
- Drive the adoption of agile practices within the team to enhance efficiency, adaptability and predicable delivery.
- Manage the product development process in an agile environment, ensuring timely and compliant software releases.
- Monitor product performance and user feedback post-launch, implementing continuous improvements and addressing any quality or compliance issues.
Regulatory & Quality Compliance:
- Ensure that the software development lifecycle complies with medical device regulations and quality standards.
- Oversee creation of release deliverables following medical device QMS, FDA Design Controls and IEC62304. Examples include software development plans, software/system requirements specifications, and risk management documents.
- Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
- Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.
WHAT YOU CAN BRING TO OUR GREAT TEAM Required:
- Bachelor's Degree in Engineering, Software, Computer Science or related discipline or equivalent experience
- 8+ years of experience as a Product Manager or similar role preferably in regulated industry
- Experience in the medical device industry
- Experience managing the process of designing, developing, and delivering innovative medical technology.
- Experience managing and successfully communicating to cross functional stakeholders.
- Experience establishing and building highly effective product development teams consisting of internal resources, contract resources, and external vendors.
- Experience managing timelines, budgets, and identifying risks
- Proven track record of working in agile environments, with strong project management and cross-functional leadership skills.
- Strong analytical and problem-solving skills, with a focus on data-driven decision-making.
Preferred:
- Master of Business Administration (MBA) or related field
- Experience leading cross functional communication and resource planning
- Extensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
- Experience working in software development tools like Jira or ADO
- Familiarity with human factors engineering and usability testing in a clinical setting.
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.
|