Baxter is looking to develop groundbreaking healthcare solutions, specifically in the area of Infusion Pump Platforms and connected Digital Applications, to transform healthcare technology and meet customer needs while adhering to the highest regulatory standards.
Requirements
- Proven experience with regulated products and connected systems in the medical devices/biotechnology industry.
- 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.
- Strong documentation skills and experience in a regulated industry.
- Experience with Agile PDLC/SDLC and Systems Engineering methodologies
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.
- Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks.
- 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 10+ years of experience, or a Master’s degree with 8+ years of experience.
- Exceptional oral and written communication skills.
- Applicants must be authorized to work for any employer in the U.S.
- Baxter is committed to supporting the needs for flexibility in the workplace, with a required minimum number of days a week onsite.
- Compliance with Baxter's flexible workplace policy, which is subject to local laws and legal requirements.
