Baxter is looking to solve complex software system challenges within their Infusion Pump Platforms and connected Digital Applications group to develop groundbreaking healthcare solutions and ensure customer needs are met while adhering to the highest regulatory standards.
Requirements
- Proven experience with regulated products and connected systems.
- 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 is preferred (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs).
- Exceptional oral and written communication skills.
- Strong documentation skills and experience in a regulated industry.
Responsibilities
- Implement best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams.
- Work on technical solutions to complex software system challenges, delivering high-quality results within tight deadlines.
- Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs.
- Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Work with cross-functional teams to ensure these needs are effectively integrated into system requirements.
- 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.
- Implement ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.
- Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods.
Other
- A Bachelor’s degree in an engineering discipline with 3+ years of experience, or a Master’s degree with 1+ years of experience.
- Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
- The flexible workplace policy is subject to local laws and legal requirements.
- This position may also be eligible for discretionary bonuses.
- Baxter is committed to supporting the needs for flexibility in the workplace.
