Baxter Healthcare Corporation is looking to develop and integrate world-class mechanical systems to improve patient care and outcomes, and this role is pivotal in achieving that goal.
Requirements
- Extensive knowledge in micro-mechanical systems, actuation using motors, and fluid pumping technologies.
- Proven experience with building for reliability, miniaturization, and high-precision motion control.
- Deep knowledge of materials, tolerance stack-up, and DFM or equivalent experience in high-volume production.
- Familiarity with regulatory standards: IEC 60601, ISO 13485, ISO 14971, FDA QSR.
- Experience with Plastics Injection Molding, Sheetmetal & casting part builds.
- Strong knowledge of DFM and DFA or equivalent experience.
- Knowledge of ISO 28620, IEC 60601, and IEC 62304 regulatory standards.
Responsibilities
- Own the mechanical subsystem architecture from concept to production, ensuring it meets clinical needs and system performance targets.
- Clearly outline and strictly follow functional and non-functional requirements, encompassing precision in flow rates and detecting occlusions.
- Evaluate and select actuation mechanisms and pumping strategies, ensuring efficient performance and compliance.
- Collaborate with cross-functional teams to successfully implement and optimize the pump drive system.
- Conduct DFMEA and FTA to determine and ensure subsystem safety and reliability.
- Apply expertise in Plastics Injection Molding, Sheetmetal & casting part builds, and strong knowledge of DFM and DFA or equivalent experience.
- Guide development validation against regulatory standards such as ISO 28620, IEC 60601, and IEC 62304.
Other
- Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or a related field.
- 10+ years of experience in medical device development, with at least 5 years in infusion pump or drug delivery systems.
- Applicants must be authorized to work for any employer in the U.S.
- Ability to work on-site at least a minimum number of days a week.
- Travel requirements not specified.
