Senior / Principal Software Engineer (Medical Device)

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• Location: San Diego, CA, 92122
• Position Type: Full Time
• Salary/Pay: $130k - $180k per year

Position Summary:

As an important member of our Device Development team, the Senior / Principal Software Engineer is responsible for embedded and application software activities across multiple projects for development of electronics based medical devices. Device firmware and software application development activities might span across pre-concept through architecture definition, development, verification, transfer, and product manufacturing.

Primary activity is development for device realization and development-iteration of manufacturing tools and test equipment. Other development may include work for the operation of low power microcontrollers including system level control and management of device components.

Requires knowledge and strong background in engineering, scientific, and regulatory aspects of medical devices and previous experience taking Class II or III devices from concept to market.

Ability to work on product development efforts individually and with team members within software, electrical, and mechanical engineering for development of novel medical devices is important for this role.

What you will be doing:

• Perform and/or lead the firmware and software development activities from pre-concept to production for medical devices of FDA major level of concern
• Create, review, revise software documentation for release per quality system
• Plan, design, develop firmware for low power microcontroller-based medical devices
• Software development for operation of device components such as sensors, LEDs, etc.
• Create, deploy software driven manufacturing and test tools for internal purposes and contract manufacturing organizations
• Work on complex issues where analysis of data and context requires in-depth evaluation of variable factors
• Collaborate with Quality team members to ensure quality standards, procedures, and methods are met and maintained throughout the development cycle
• Collaborate with internal and external engineers on incorporation of product development needs, software driven algorithms, and data processing modules
• Help drive and manage software project timelines, resource needs for device projects
• Provide timely updates to manager on project development status, issues, discoveries
• Work with software test staff to ensure proper test plans are created, executed
• Contribute to device history, risk mitigation, and quality documents of devices moving towards regulatory filings (i.e., 510k, De Novo 510K and PMA)
• Perform other duties as they are identified to support cross-functional teams

What you will need:

• Minimum BS in SWE, EE, CE, CSE
• Evidence of full medical device life cycle at one company (concept to production)

• Senior level position:
• 10 years overall experience
• 5 years experience in medical devices, preferably drug/device combinations

• Principal level position:
• 15 years overall experience
• 8 years experience in medical devices, preferably drug/device combinations

• Familiarity with architectures for complex electromechanical systems
• 5 years firmware development in C/C++
• Familiarity with medical standards for engineering design and test
• Familiarity with medical ISO/IEC processes such as 13485, 14971, 62304
• Have worked to the actual standards, not just company specific processes
• Developed product and composed FDA-compliant documentation
• Experience in project setup for successful testing at V&V stages
• Solid work ethic and communication skills
• Ability to work autonomously, handle multiple project and priorities, good project management skills
• Working knowledge of medical device manufacturing requirements and needs
• Design controls experience with FDA QSR 21 CFR Part 820 and ISO 13485
• Strong knowledge of I2C, SPI, UART protocols and driver development
• Experience working STM 32-bit Cortex M-processors or similar
• Strong object-oriented programming and design skills
• Experience in writing control software (C#/Python) for custom test equipment supporting medical device development
• Understanding of electronics components, systems, and circuit design
• Experience in configuring and managing a software revision control
• Document generation and practices for approval of software driven medical devices
• Strong mathematical skills and understanding of data processing methods for real time algorithm deployment
• Knowledge of Eclipse, Atollic TrueSTUDIO, or similar IDEs
• Ability to communicate at all levels of the organization and perform/lead with influence
• Proactive, forward-thinking, and creative with high ethical standards, leadership skills
• Ability to influence others to achieve successful outcomes and meet timelines
• Ability to function efficiently, effectively, and at times independently in fast-paced, changing environment
• Strong team player with mindset aligned with our corporate values

Application process:

1. Hit APPLY. If successful, you will receive an email within 24 hours asking you to answer a few pre-qualifying questions. Please return these ASAP

2. If pre-qualifying answers are successful, you will receive an email requesting a 5 minute verifying call.

3. Client team (HM) will take you through their process which is generally a quick turnaround.