Principal Software Systems Engineer

Responsibilities

As a Principal Software Systems Engineer, your responsibilities will include:

• Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams.
• Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
• Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines.
• Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs.
• User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements.
• Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks. Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools.
• Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.
• Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods.
• Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality.
• Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
• Stakeholder Collaboration: Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures.
• Design Transfer Process: Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process.
• Issue Resolution: Lead/assist in technical investigations for field issues and product complaints, with appropriate impact assessments on requirements and risks.
• Compliance Assurance: Uphold compliance with the product development process and quality system standards.

Qualifications

• A Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience.
• Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs.
• Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus.
• Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred.
• Exceptional oral and written communication skills.
• Strong documentation skills and experience in a regulated industry.

Benefits

• Paid Leave
• Health Insurance
• Group life insurance
• Disability
• 401(K)

Salary

The expected salary range for this position is between $60,000 to $1,15,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.