The Role
Leads embedded systems development and testing for medical devices, overseeing architecture, firmware, hardware integration, verification, validation, automation, quality, regulatory compliance, and product release. Manages engineering teams, establishes technical strategy and metrics, drives root-cause analysis, coordinates cross-functional execution, supports risk management and audits, and develops engineering talent across the product lifecycle.
Summary Generated by Built In
Work Flexibility: Hybrid
We are seeking an experienced Manager – Embedded Systems Development & Testing to lead a high-performing engineering team responsible for the design, development, integration, verification, and validation of embedded systems for next-generation medical devices.
The role will provide technical and people leadership across the embedded product lifecycle, from requirements and architecture through software/hardware development, system integration, verification, validation, and product release.
The ideal candidate will have strong experience in embedded software, real-time systems, hardware/software integration, automated testing, system verification, and regulated product development, combined with the ability to build and lead engineering teams.
What You will do:
Key Responsibilities
1. Engineering Leadership
- Lead and manage embedded systems development and testing teams responsible for medical device products.Define engineering strategies, development processes, technical direction, and execution plans.
- Provide technical leadership across embedded software, firmware, system integration, and verification.Drive execution of multiple concurrent projects while balancing quality, schedule, cost, and technical risks.
- Establish clear ownership, accountability, and engineering metrics across the team.Partner with Product Management, Systems Engineering, Quality, Regulatory, Manufacturing, Clinical, and other cross-functional teams.
2. Embedded Systems Development
- Lead development of embedded software/firmware for medical devices and connected systems.Guide architecture and design decisions involving:Embedded C/C++RTOSMicrocontrollers and SoCsDevice driversCommunication protocolsUSB/BLE/Wi-Fi/EthernetSensor interfacesMotor/control systemsPower managementBootloaders and firmware update mechanisms
- Ensure robust hardware/software integration and system-level performance.Drive reuse of software platforms, common architectures, libraries, and development frameworks across products.
3. Verification & Validation
- Lead development and execution of unit, integration, system, and acceptance testing strategies.Establish robust verification methodologies for embedded software and complete medical-device systems.
- Drive automated testing, hardware-in-the-loop (HIL), simulation, test automation, and continuous integration where appropriate.Ensure traceability between:
User Needs → System Requirements → Software Requirements → Design → Implementation → Verification - Review and approve verification strategies, test plans, test cases, and test results.Drive root-cause analysis and resolution of complex technical issues discovered during development and testing.
4. Quality & Regulatory Compliance
- Ensure engineering activities comply with applicable medical-device development processes and organizational quality systems.Work closely with Quality and Regulatory teams to ensure compliance with applicable standards and regulations, such as:ISO 13485IEC 62304IEC 60601, where applicableISO 14971IEC 62366, where applicableCybersecurity requirements applicable to medical devicesApplicable FDA and international regulatory requirements
- Ensure appropriate documentation, design controls, risk management, change control, and verification evidence throughout the product lifecycle.Participate in design reviews, risk reviews, audits, and regulatory submissions as required.
5. Test Automation & Engineering Excellence
- Establish a modern automated testing strategy for embedded products.Increase automated test coverage and reduce dependence on manual testing.
- Promote:CI/CD for embedded systemsAutomated regression testingHardware-in-the-loop testingStatic and dynamic analysis Code coverage Unit testing Integration testing System-level testing. Establish engineering metrics to monitor product quality, test effectiveness, defect escape rates, and development efficiency.
6. Technical Problem Solving
- Act as an escalation point for complex embedded-system issues.Lead cross-functional investigation of difficult hardware/software/system failures.
- Drive structured root-cause analysis using methodologies such as 5-Why, Fishbone, FMEA, and fault-tree analysis.Ensure corrective and preventive actions are implemented effectively.Provide technical guidance during field issues, customer escalations, and product investigations.
7. People & Talent Leadership
- Build, mentor, and retain a strong embedded engineering organization.Define team structure, roles, responsibilities, and technical career paths.Conduct performance management, coaching, and regular career development discussions.
- Identify technical skill gaps and establish training and development plans.Recruit high-quality embedded software, firmware, systems, and test engineers.Develop future technical leaders and engineering managers.
8. Project & Program Execution
- Work with program/project managers to develop realistic technical schedules and resource plans.Identify technical risks early and establish mitigation plans.
- Track milestones, dependencies, defects, technical debt, and engineering deliverables.Communicate project status, risks, and opportunities to senior leadership.Support product launches and sustaining engineering activities.
What You Need:
Must Have
- 13-16 years embedded systems experience with 5+ years people-management/technical leadership.
- Strong embedded architecture and system-design knowledge across software, hardware, RTOS, drivers, and interfaces.
- Proven experience leading teams through end-to-end product development from requirements to release and sustaining.
- Strong understanding of verification, testing, quality, risk management, and regulated product development.
- Strong people leadership, mentoring, cross-functional influence, and execution skills.
Good to have
- Medical-device / safety-critical / regulated product development experience.
- Experience with manufacturing/NPD, production, and sustaining engineering.
- Hands-on knowledge of motor control, electromechanical systems, embedded Linux, connectivity, and cybersecurity.
- Experience with automation, HIL, CI/CD, static analysis, and automated testing.
- Previous experience as a Senior Staff/Staff Engineer or Embedded Architect before moving into people management.
Skills Required
- 13–16 years of embedded systems experience
- 5+ years of people management or technical leadership experience
- Strong embedded architecture and system design knowledge across software, hardware, RTOS, drivers, and interfaces
- Experience leading end-to-end product development from requirements through release and sustaining engineering
- Strong understanding of verification, testing, quality, risk management, and regulated product development
- Strong people leadership, mentoring, cross-functional influence, and execution skills
- Medical-device, safety-critical, or regulated product development experience
- Experience with manufacturing, new product development, production, and sustaining engineering
- Hands-on knowledge of motor control, electromechanical systems, embedded Linux, connectivity, and cybersecurity
- Experience with automation, hardware-in-the-loop testing, CI/CD, static analysis, and automated testing
- Previous experience as a Senior Staff Engineer, Staff Engineer, or Embedded Architect
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
