Senior Technical Project Manager, R&D HW/FW

iRhythm Technologies, Inc.; San Francisco (CA); Hybrid; USD 158,000 - 206,000; Full time

Job summary

iRhythm is seeking a Senior Technical Project Manager in the Research & Development team to lead embedded hardware and firmware initiatives from concept to production for medical devices. You will drive planning, execution, and delivery across domestic and international markets in a fast-paced, patient-focused environment.

In this hybrid SF-based role, you will collaborate with product management, engineering, QA/RA, and manufacturing, serve as Scrum Master, and ensure rigorous design controls

Qualifications

• BS in Engineering or related technical field.
• MBA or PMP certification is a strong plus.

Responsibilities

• Collaborate with product management, engineering, quality and regulatory to define scope for unmet clinical needs and launch new products.
• Drive project planning, WBS, estimation, resources, scheduling, risks and re-planning for embedded hardware and firmware components.
• Maintain the technical project release plan as it pertains to the design control process.
• Primary owner of project plan initiation through post-implementation.
• Lead cross-functional collaboration with CRM, Manufacturing, Marketing, Customer Support, and Clinical Operations.
• Ensure all documentation supporting change requests and design change plans comply with SOPs/regulatory standards.
• Act as a Scrum Master for sprint planning, backlog refinement, stand-ups, and retrospectives.
• Lead stand-ups and recurring project meetings to track progress, timelines, health and risks.
• Facilitate technical discussions within engineers and cross-functional teams.
• Own the project risk register and discuss risk management activities.
• Work with QA/RA to ensure activities comply with regulatory standards.

Skills

Embedded HW

Firmware

Project mgmt

Cross-functional

Regulatory readiness

Education

BS in Engineering

MBA or PMP

Tools

JIRA

Confluence

Job description

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role

iRhythm is currently seeking an experienced Senior Technical Project Manager within the Research & Development team. This Technical Project Manager is focused on embedded hardware and firmware with responsibility for leading the planning, execution, and delivery of complex embedded systems products from concept through production. You will have the opportunity to drive the delivery of medical device projects to domestic and international markets. You will be exposed to a diverse set of projects involving development and testing in the context of addressing unmet clinical needs. In addition, you will build a deep understanding of our end-to-end systems, helping to drive successful delivery of projects throughout the development life cycle.

Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

Specific Job Responsibilities Include

Project Planning

• Collaborate closely with product management, engineering, quality and regulatory assurance to understand and distill business priorities to develop project scope for unmet clinical needs and launch new products


• Drives project planning, WBS, estimation, resources, scheduling, timelines, “what-ifs”, risks and re-planning as required with focus on embedded hardware and firmware components.


• Create and maintain the technical project release plan as it pertains to design control process

Project Execution

• Primary owner of project plan initiation through post implementation


• Successful project execution and launch with a mix of people skills, project management, technical expertise and cross functional collaboration with CRM, Manufacturing, Marketing, Customer Support, and Clinical Operations


• Ensures all technical project documentation supporting change requests, design change plans, closure forms is executed timely and in compliance with company SOPs/Regulatory standards.


• Act as a scrum master for sprint planning, backlog refinement, stand-ups, and retrospectives


• Lead and drive stand-ups, recurring project meetings to track progress, timelines, project health and risks


• Facilitate and participate in technical discussions within technical engineers and cross-functional teams


• Own project risk register and hold regular discussions on risk management activities.


• Work closely with QA/RA to ensure activities performed in compliance with Company SOPs/International Regulatory standards.

Operational

• In conjunction with technical project management team, own health of projects undertaken and drive continuous improvement of processes


• Drive best practices on the team, deal with ambiguity and competing objectives


• Participate in production release/health monitoring activities.

Required Qualifications

• BS degree in Engineering or related technical field required


• Master’s degree, M.B.A. or P.M.P. certification a strong plus


• 4+ years’ experience leading development projects, ideally with a demonstrated record of transferring design changes to manufacturing and taking new products from development to commercialization.


• 8+ years of engineering experience in a professional environment, requiring extensive cross-functional collaboration.


• Proven ability to influence without authority, enabling coordination and alignment of matrixed resources.


• Strong project management skills including budgeting, planning, tracking, organization, attention to detail, managing competing priorities, analytical and critical thinking, and sound engineering fundamentals


• Strong technical abilities, grounded in ethics and sound decision-making processes.


• Deep familiarity with highly technical product development teams and design transfer processes with embedded systems - medical device experience is strongly preferred.


• Excellent interpersonal skills, enabling strong alignment with internal / external partners and can navigate conflict constructively.


• Effective communication and presentation abilities, with demonstrated ability to synthesize information clearly and convey technical concepts to non-technical audiences.


• Software/tools: Proficient using Microsoft Office Suite, including Project and Visio. Working knowledge of Atlassian tools (JIRA, confluence) a plus.


• Travel up to 10% (team meetings/offsites)

Preferred Qualifications

• Master’s in science or technical field is a plus


• Experience in the medical device industry is a plus


• Experience with IEC standards 62304, 14971, 62366


• Experience with Tools desired – Jira, Confluence, Requirements management (JAMA)


• Proficiency in AWS/Linux/Unix/Windows environment

Location: Hybrid (San Francisco, CA)

San Francisco

Estimated Pay Range

$158,000.00 - $206,000.00

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail]

Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

About IRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.