Previous Job
Project Engineer - Medical Device IV
Ref No.: 18-23060
Location: Concord, California
TITLE :             Project Engineer - Medical Device IV
LOCATION:     Concord, CA
Duration:        6 months

EDUCATION: Minimum of a bachelor's degree is biology or chemical engineering
This position will have the primary responsibility for delivering and executing a design history file remediation plan for electromechanical medical equipment.
In partnership with cross-functional team members, the position will ensure that a mature product line meets current regulations and best practices for medical electrical equipment, disposables (i.e. accessories) and reusable goods.
​A successful outcome guarantees the product will continue to serve patients with the high level of quality and reliability they expect from the brand. 

• Comprehend existing Design History File documentation, including Design Input, Design Output and Post-Market activities
• Using gaps identified in a comprehensive Design History File audit, clarify and identify a succinct plan for closing gaps and prioritize work required to do the same
• Demonstrate proficiency in medical device regulation(s), standards and current best practices as they apply to reusable medical electrical equipment
• Remediate, in collaboration with a cross-functional team, the design history file, including product requirements, design specifications, component drawings and design traceability
• Under minimal direction, prepare updates to system specifications, design documentation, test descriptions, hazard analysis, validation test procedures, and related documentation supporting software, hardware and product development to known standards
• Define, write and execute engineering test protocols, analyze data and create summative test reports
• Demonstrate proficiency in Human Factors Engineering and IEC 62366 for Usability Engineering; elaborate on use-related errors, user-based risk management and create usability engineering file
• Must have experience in the medical device field with requirements development, test methods, protocol and report writing, design verification and experience presenting technical concepts to different levels within the organization.
  • Minimum 5 years’ experience in medical device product development and/or sustaining activities
  • Bachelor's degree; science or engineering degree preferred
  • Experience with software development lifecycle in a regulated environment highly desirable.