Delegation Audit Specialist
Capital Rx
Cloud
System Engineer I
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Massachusetts
Visit company websiteSalary
💰 $54,000 - $108,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Cloud
About the role
- Analyze input requirements for medical devices and translate these into specific system requirements and interface specifications.
- Document system requirements using requirement management tools; write documents, reports, memos, change requests, etc.
- Update and maintain feature specifications in narrowly defined areas for specific projects.
- Participate in cross-functional review of design documentation and analyses and present systems engineering documentation in review meetings.
- Plan, coordinate, and develop system evaluation and testing activities based on analysis of system requirements, user needs, and system design.
- Simulate or test aspects of new products or algorithms to evaluate prototypes, verify design meets requirements, and validate performance for intended use.
- Provide input into development of system verification plans and procedures and execute those tests.
- Document results and write test reports demonstrating safety and efficacy for regulatory review.
- Conduct feasibility studies, benchmarking, reliability testing, and interaction testing.
- Assist in troubleshooting issues to determine root cause and possible engineering solutions; apply systematic problem-solving methodologies.
- Collaborate across disciplines and communicate at multiple levels within the organization; work independently and within a team in a fast-paced environment.
Requirements
- Bachelor’s degree in engineering (Biomedical, Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline (required).
- Advanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline (preferred).
- 6 months’ experience in medical product development (preferred).
- Class III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems (preferred).
- Experience with biologic sensors (flow, pressure, EKG, etc.) (preferred).
- Experience and expertise with systems consisting of hardware, software, mobile app, and cloud components.
- Experience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologies.
- Knowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices.
- Experience effectively integrating information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs.
- Strong verbal and written communications skills.
- Ability to multitask, prioritize, and meet deadlines.
- Strong organizational and follow-up skills, with attention to detail.
- Ability to work independently with minimal supervision.
