Medical Device Engineer Job at EPITEC, Pleasanton, CA

N1dpUDJoanVuQU0wcStMR1pTSktEYmoyY1E9PQ==
  • 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,

Similar Jobs

Eurofins USA PSS Insourcing Solutions

Scientist - Analytical Process Support Lab Job at Eurofins USA PSS Insourcing Solutions

 ...Description This position will provide hands-on support to the labs process development, process monitoring, and manufacturing...  ...full-time benefits including comprehensive medical coverage, dental, and vision options ~ Life and disability insurance ~401(k)... 

ABB

Resident QCS Service Technician - Monticello, MS Job at ABB

Resident QCS Service Technician - Monticello, MS We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and learn about the impact of our solutions across the globe. #MyABBStory This position reports to ...

Seattle Children's

Registered Nurse (RN) - Psychiatric Job at Seattle Children's

 ...Job Description Seattle Children's is seeking a Registered Nurse (RN) Psychiatric for a nursing job in Seattle, Washington. Job Description...  ...and Behavioral Medicine Unit (PBMU)! No pediatrics experience? No problem! If you have experience working with adult... 

Adelphi Medical Staffing, LLC

Urgent Care Physician Assistant Job at Adelphi Medical Staffing, LLC

 ...Job Quick Facts Specialty: Urgent Care NP/PA Job Type: Locum Facility Location: North Carolina - Apex, Durham, Roxboro...  ...- Center Manager, PSA, 1 MA, 4 Office Staff - Supervising Physician Offsite (for APP only) Procedures: L&D, Lac Repair, Ear... 

Interstate Waste Services

Class B Roll Off Driver Job at Interstate Waste Services

Overview: Interstate Waste Services is Now Hiring CDL B Roll Off Truck Drivers in Paterson! Safety is our first Priority! This position requires Roll-Off experience. Please note: In order to be considered for this position, you will need to upload your resume...