Title : Sr. R&D Engineer
Duration: 12+ months Contract -Possibility of extension
Location: Hybrid/San Diego CA .
Job Description:
Possibility of extension
On site 4 days a week
Travel 10%
We are seeking a highly skilled and experienced R&D Engineer to join our R&D Released Product Management (RPM) team, which supports Alaris infusion products. The ideal candidate will have a strong background in medical device engineering and a deep understanding of industry standards and methodologies. They will wear multiple hats and work with core team members across engineering and project disciplines.
Key Responsibilities:
• Conduct root cause analysis and implement corrective actions for product issues.
• Support product design changes and ensure they meet regulatory and quality standards.
• Decompose system requirements into subsystem or component specifications
• Develop and execute test documentation for verification and compliance testing
• Coordinate activities related to product changes with multiple cross-functional teams, including operations, quality, regulatory, and others.
• Evaluate risks associated with product changes and provide mitigation strategies.
• Provide input on reliability, verification, and validation testing.
• Ensure compliance with ISO 13485, 14971, CFR21, CSA and other relevant regulations and standards.
• Utilize statistical testing methods and design for manufacturing (DFM) and design for six sigma (DFSS) methodologies.
• Collaborate with cross-functional teams to ensure successful product updates and solve complex problems under time sensitive deadlines
• Maintain thorough documentation of design changes, testing results, and risk assessments.
• Interact with hardware suppliers to ensure design for manufacturability, testability and overall reliability
Qualifications:
• Bachelor's, Master's or PhD degree in Electrical Engineering or a related field.
• Minimum 5 years of related experience.
• Experience with Systems Engineering
• Track record of working successfully in a rapidly changing environment with high levels of uncertainty
• Strong understanding of ISO 13485, 14971, and other relevant standards.
• Basic knowledge of PCB and PCBA design
• Experience with laboratory tools: oscilloscope, DMM, variable DC power supply, etc.
• Experience with troubleshooting of electromechanical devices
• Basic knowledge of product safety and compliance design and testing
• Proven experience with structured problem solving, 8D, CAPA and other problem methodologies
• Knowledge of regulatory requirements for medical devices
• Experience with risk management and failure mode and effects analysis (FMEA).
• Experience with statistical testing methods.
• Excellent problem-solving skills and the ability to work in a fast-paced environment.
• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
• Ability to manage multiple projects and priorities simultaneously.
• Proficiency in using engineering tools and software for design and analysis.
Preferred Qualifications:
• Master’s or PhD degree in Electrical Engineering or related discipline.
• Experience with Alaris infusion products or similar medical devices.
• Certification and experience in design for manufacturing (DFM), design for six sigma (DFSS) methodologies.
• Critical components and critical parameters management experience.
Key Skills: