Baxter is looking to develop groundbreaking healthcare solutions, specifically within their Infusion Pump Platforms and connected Digital Applications group, to meet customer needs while adhering to the highest regulatory standards. This involves addressing complex software system challenges and ensuring the quality and compliance of new product development and sustaining activities.
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 requirement tracing methods.
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.
- 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.
