Senior Staff Firmware Developer

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Senior Staff Firmware Developer owns the design, development, and optimization of firmware and embedded software components for Cocoon® Platform. They play a meaningful role in ensuring compliance with regulatory standards and industry best practices while delivering innovative and reliable embedded software solutions that meet the outstanding requirements of the medical device industry. This role requires a solid technical background in firmware and embedded software development, deep technical leadership skills along with the ability to collaborate optimally with multi-functional teams to drive the successful delivery of software projects.

Key Responsibilities:

• Accountable for product architecture and design decisions related to firmware, embedded software, and integration of software, firmware and hardware components.

• Firmware Development: Lead the design, implementation, and optimization of firmware solutions, ensuring adherence to regulatory standards and quality requirements.

• Embedded Software Design: Design and develop embedded software solutions, including device drivers, communication protocols, and real-time operating systems (RTOS), to support the functionality and performance requirements.

• Testing and Verification: Identify and implement tools and equipment required for firmware / embedded software unit testing and verification, including automated testing.

• Regulatory Compliance: Ensure that firmware and embedded software solutions comply with regulatory requirements for medical devices, including safety, security, and quality standards, and participate in regulatory submissions and audits as needed. Maintain a deep understanding of industry regulations and standards, ensuring that the firmware and embedded software development processes comply with relevant guidelines (ISO 62304, FDA 21 CFR Part 11, ISO 13485).

• Cross-Functional Collaboration: Collaborate closely with hardware engineers, systems engineers, MSAT, and regulatory affairs professionals to define software requirements, design constraints, and system architectures.

• Performance Optimization: Optimize firmware and embedded software for performance, power efficiency, and reliability, leveraging best practices in embedded system design and implementation.

• Risk Management: Conduct risk assessments and hazard analyses for firmware and embedded software components, identifying and mitigating potential risks to patient safety and device functionality.

• Documentation and Traceability: Maintain thorough documentation of firmware and embedded software designs, requirements, and test results, and establish traceability between software artifacts and regulatory requirements.

Key Requirements:

• Extensive experience in firmware development for medical imaging devices, patient monitoring systems, regulated medical devices, or lab equipment.

• Proficient in programming MCUs based on Arm® Cortex®-M7 core in C/C++ using NPX MCUXpresso IDE, and debugging with J-Link adapter.

• Skilled in building embedded solutions with μTasker RTOS and integrating peripherals such as GPIO, UART, SPI, ADC, USB, and CAN.

• Experience implementing data interfaces for hardware integration using CANbus, Serial Port, MODbus, and Object Dictionaries.

• Strong background in developing PID and advanced control logic algorithms in firmware.

• Experience with firmware testing through Python scripts, VectorCAST automation, and using hardware communication tools like PuTTY.

• Familiar with Agile methodologies (Scrum, Kanban) using Azure DevOps, and working in regulated environments with quality management systems (QMS).

Soft Skills:

• Excellent problem-solving, attention to detail, and the ability to work effectively in cross-functional teams.

• Strong communication skills, with the ability to explain technical concepts to non-technical stakeholders.

• Proven leadership in mentoring software developers and testers, fostering innovation and collaboration.

The ideal candidate will be geographically located in the East coast or Midwestern US. Approximately 10% travel required, including internal meetings.

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