Senior Principal Embedded Software Engineer, Medical Devices

Baxter Healthcare

Town of Skaneateles (NY)

On-site

USD 144,000 - 198,000

Full time

14 days+

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Medical coverage

Dental coverage

Life and disability insurance

401(k) with company matching

Employee Stock Purchase Plan

Paid holidays

Paid time off 20–35 days

Parental leave

Commuting benefits

Job summary

Baxter in Skaneateles, NY seeks a Senior Principal Software Engineer to lead embedded software development for medical monitors, shaping architecture, design, documentation, and sustaining engineering across products.

The role demands hands-on technical leadership, deep knowledge of RTOS and Embedded Linux, and the ability to guide a small team while meeting regulatory requirements and delivering high-quality solutions.

Qualifications

Bachelor's degree in Engineering, Computer Science, or a related technical discipline, or equivalent combination of education and experience.
10+ years of experience developing embedded software for complex products, including regulated, safety-critical, or medical device systems.
Strong technical expertise in embedded C/C++, RTOS environments (e.g., ThreadX), Embedded Linux, kernel/driver development, networking protocols, and multi-threaded systems.
Proven experience designing and architecting embedded systems, with a track record of delivering innovative, high-quality solutions for released products.
Demonstrated technical leadership experience guiding senior engineers, architects, and cross-functional development teams through complex projects.
Strong problem-solving and communication skills, with the ability to decompose complex architectures and articulate technical solutions across internal and external interfaces.
Experience working within regulated development environments, including Agile/Lean practices, risk management, quality systems, cybersecurity, and product lifecycle processes.
Preferred qualifications include an advanced engineering degree, knowledge of medical device standards and regulations (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, IEC 81001-5-1), and experience supporting regulatory submissions such as 510(k), De Novo, PMA, or EU MDR.

Responsibilities

Own the end-to-end software development lifecycle for medical device products, from requirements and architecture through design, implementation, verification, release, and sustaining support.
Define and drive technical roadmaps, architecture strategies, and technology selections aligned with product goals, regulatory requirements, and long-term maintainability.
Identify, assess, and mitigate product-level technical risks, partnering with cross-functional teams to develop effective recovery and risk management plans.
Provide technical leadership and guidance across development, verification, integration, design transfer, and field issue resolution activities.
Ensure compliance with medical device quality and regulatory standards, including risk management, complaint handling, CAPA support, cybersecurity, and design control processes.
Champion quality, security-by-design, reliability, manufacturability, serviceability, and continuous improvement throughout the product lifecycle.
Establish and maintain high technical standards through design reviews, technical oversight, mentoring, talent development, and participation in hiring and technical assessments.
Lead and influence cross-functional teams using Agile SAFe practices, collaborating with Quality, Regulatory, Clinical, Human Factors, Manufacturing, Service, Supply Chain, and Program Management to deliver compliant, high-quality solutions.