Baxter is looking to solve complex software system challenges within their Infusion Pump Platforms and connected Digital Applications group, ensuring adherence to regulatory standards and meeting customer needs for groundbreaking healthcare solutions.
Requirements
- 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.
- Strong documentation skills and experience in a regulated industry.
Responsibilities
- 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.
- Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
- Develop innovative 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. Lead 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.
- Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.
Other
- A Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience.
- Exceptional oral and written communication skills.
- 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.
