Design Control Program Manager

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview  

The Design Control Program Manager leads the planning, coordination, and execution of cross-functional programs subject to Design Controls, including software, hardware, integrated product, remediation, design change, and other strategic initiatives. This role partners with Engineering, Quality, Regulatory Affairs, Clinical, Operations, Manufacturing, Supply Chain, external partners, and leadership stakeholders to drive execution readiness, manage risks and dependencies, and provide clear program and portfolio visibility in a regulated environment. 

The role develops and maintains integrated project plans, facilitates governance and decision-making forums, tracks actions and milestones, supports resource and roadmap planning, and ensures teams remain aligned on priorities, commitments, and recovery plans. 

Essential Job Functions and Responsibilities  

• Develop, maintain, and manage integrated program plans, schedules, milestones, critical paths, and dependencies across software, hardware, integrated product, remediation, design change, and ad hoc projects. 

• Facilitate planning sessions and establishrealistic execution timelines based on scope, resource availability, technical dependencies, and quality or regulatory requirements. 

• Lead program team meetings, governance forums, phase-gate reviews, design reviews, and planning reviews to drive decisions, alignment, and timelyfollow-up. 

• Coordinate work across Software Engineering, Hardware Engineering, Systems Engineering, Quality Assurance, Regulatory Affairs, Operations, Clinical, Manufacturing, Supply Chain, and external partners. 

• Maintain RAID logs, risk registers, action trackers, and dependency logs; drive risk identification, prioritization, mitigation, escalation, resolution, and recovery planning. 

• Track cross-functional commitments, milestones, overdue actions, verification activities, defect assessments, testing impacts, remediation work, and implementationreadiness. 

• Prepare and communicate program status, executive dashboards, review materials, leadership presentations, risks, dependencies, resource constraints, key decisions, and recovery plans. 

• Maintain product roadmaps, design change plans, release plans, implementation plans, and reporting dashboards using Smartsheet, Jira, Microsoft Project, or comparable tools. 

• Partner with Quality and Regulatory teams to understand requirements related to design and development, design changes, verification, validation, remediation, manufacturing implementation, and product release activities. 

• Support resource planning, roadmap development, scenario analysis, portfolio prioritization, and leadership decision-making. 

• Promote accountability, collaboration, and cross-functional alignment through effective facilitation, stakeholder engagement, and clear communication. 

• Manage change within assigned programs by helping teams adapt to shifting priorities, changing conditions, and unexpected obstacles while maintainingfocus on program outcomes. 

Required Qualifications  

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Technical Management, or a related field; master’s degree preferred. 

• Minimum of 5 years of project or program management experience, including at least 3 years leading projects subject to Design Controls. 

• Demonstrated experience managing multiple concurrent product development, design change, remediation, or cross-functional projects from planning through execution and implementation. 

• Experience developing and maintainingintegrated schedules and managing cross-functional dependencies, risks, issues, decisions, milestones, and recovery plans. 

• Experience applying Agile, Scrum, hybrid, stage-gate, or traditional project management methodologies based on project needs. 

• Experience using Smartsheet, Jira, Azure DevOps, Microsoft Project, Excel, PowerPoint, Word, or comparable project and portfolio management tools. 

• Strong written, verbal, and interpersonal communication skills, including the ability to present complex programs clearly to leadership, customers, and cross-functional stakeholders. 

• Strong leadership and influencing skills, with the ability to engage, motivate, and align cross-functional teams across multiple business functions and organizational levels. 

• Ability to anticipatechallenges, balance competing priorities, navigate organizational complexity, and make timelydecisions with incomplete information and under pressure. 

• Advanced English proficiencyin written and spoken communication; strong organization, facilitation, change management, and customer-focused problem-solving skills. 

Desired Qualifications  

• PMP, Agile, Scrum, or equivalent project or program management certification. 

• Experience in medical device, healthcare technology, or other FDA-regulated or highly regulated product development environments. 

• Familiarity with verification and validation, risk management, design transfer, manufacturing implementation, product release, sustaining engineering, or post-market activities. 

• Experience supporting remediation programs, CAPA-related initiatives, audit readiness, inspection response, or quality system improvement efforts. 

• Working knowledge of quality management systems, design change controls, and applicable software, hardware, or integrated product lifecycle requirements. 

• Advanced experience with Power BI, PPM platforms, portfolio dashboards, executive reporting, or portfolio-level resource and scenario planning. 

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy Notice.  

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at [email protected].

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT  

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.