Medical Device Engineer Job at EPITEC, Pleasanton, CA

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  • EPITEC
  • Pleasanton, CA

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).

Job Tags

For contractors, Work experience placement,

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