Product Manager, Programming SoftwareNew

About the position

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.

Responsibilities

• 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 predictable 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.
• 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.
• 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.

Requirements

• 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.

Nice-to-haves

• 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

• 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.
• Opportunity to participate in the ownership and success of Inspire through equity awards and the Employee Stock Purchase Program.