Baxter is looking to develop groundbreaking healthcare solutions and redefine healthcare delivery by improving infusion pump platforms and connected digital applications, ensuring customer needs are met while adhering to regulatory standards.
Requirements
- Proven experience with regulated products and connected systems in the medical devices/biotechnology industry.
- 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.
- Familiarity with electro-mechanical devices is preferred.
- Experience in creating and maintaining product backlogs.
- Experience with requirements management.
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.
- 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.
- Strong documentation skills and experience in a regulated industry.
- The flexible workplace policy is subject to local laws and legal requirements.
- This position may also be eligible for discretionary bonuses.
