Job Description

Pleasanton, CA

100% Onsite Role

Job Summary

Seeking a Medical Device Engineer to help integrate mobile systems and wireless technologies into medical devices, performing formal verification, and adhering to the design change control process.

RESPONSIBILITIES

• Plans, manages, and reports on overall systems integration.
• Generates / Supports the systems integration plan and report.
• Coordinates system engineering testing to verify systems functionality including software.
• Drives and records configuration of system at integration points.
• Supports system design change control process.
• Leads / Executes system verification execution.
• Identifies and escalates risks in terms on systems viability with existing requirements.
• Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
• Ensures tracing from requirements to test. Working experience with Requirements Managements tools e.g., DOORS, JIRA etc.; use and administration of DOORS a plus.
• Experience in understanding medical device standards (62304, 60601, etc.) a plus
• May support Internal and External Audits, as directed by management.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Anticipated business travel around 10%.

Required

• Bachelor’s degree in engineering and/or Science with 1+ year of experience in developing highly engineered products (at least 1 year in medical/diagnostics products), or an equivalent combination of education and experience.

• Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).

• Systems engineering experience in a highly regulated industry

• Excellent verbal and written communication skills, with ability to communicate effectively to Core Team.

• Previous experience working in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Preferred

• Master’s degree in engineering (Computer, Electrical, Mechanical, Computer Systems, or Software), Computer Science, or related discipline.

• Medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc).

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