Description
*Looking for only 1-5 Years Experience*PRINCIPAL DUTIES AND RESPONSIBILITIES:
*Essential Functions
Product Development Engineering Support:
- Execute and draft HW verification/validation testing (protocols and reports) including test fixtures for electrical systems or PCBAs.
- Understand and able to calculate and perform analog circuit analysis*
- Responsible for all Design Assurance functions pertaining to New Product Development for Product SW and Computer system validation for product SW.*
- Participate as a core team member throughout the product development process and provide SW risk management support per IEC62304 and follow-up.*
- Execute and draft SW validation testing including test cases for embedded SW (IEC62304) and production SW/computer systems (CFR Part 11).*
- Document and track SW defects via Mantis (SW defect tracking too) and driving code review with documented risk characterization of such defects.*
- Support other relevant testing including protocol and report generation that may include electrical and software disciplines.*
- Assist in design transfer by reviewing and ensuring DMR activities are complete for new products.
- Build electrical and automation text fixtures for laser console reliability testing.
- Develop and lead quality plan initiatives.
- Through risk management, use of statistical methods, design and process control activities, the QE will ensure that our products satisfy the needs of the customer.
- Participate on Design Assurance improvement programs to improve overall quality of new product designs and regulatory compliance.
- Monitor the design controls portion of the quality system for regulatory compliance.
- Ensures critical design characteristics are properly identified for correct levels of controls.
- Support teams that focus on Risk Analysis to include Risk Assessments, DFMEA's & PFMEA's.
- Help drive the Corrective Action process.
- Support various reviews throughout a project to include Phased Gate Design Reviews, Product Safety Committee, and Post Product Launch Analysis.
- Other tasks as assigned.
Sustaining Engineering support
- Provide manufacturing support and support relevant validation activities that may include process (IQ, OQ, PQ) or test method validation.
Team Support
- Supports project teams by promoting implementation of quality principles at the design and initial manufacturing stage of product development.
- Participate in process validation or qualification studies that may contain elements of
- Independently identifies and implements improvements to the quality and effectiveness of products and processes.
- Support internal/external audits as needed.
Technical Support
- Supports investigation, prioritization and coordination of proposed documentation changes.
- Provides technical assistance for incoming inspection and manufacturing quality problems.
- Selects and applies appropriate statistics techniques for testing of materials and incoming components.
QUALIFICATIONS:
Education:
- Bachelor's degree in Electrical/Computer Engineering or Computer Science
Experience:
- Minimum of 0-2 years medical device and/or drug manufacturing/quality systems
- Strong background in statistical techniques, measurement tools and SPC tools
- Preferably knowledgeable in Quality System Regulations, Medical Device Directive, ISO14971, ISO62304, IEC, , and ISO13485 Quality Standards.
- QSR/ISO auditing experience
- ASQ or other quality related certifications (CQE, CQA, CRE, ISA Lead Assessor)
Skills:
- Must be able to read and interpret electrical drawings (PSICE, ORCAD), SW code (C, PERL) and design specifications
- Must be proficient in technical writing skills with clear, effective and concise communications
Physical Requirements:
- Able to lift 25 lbf.
- 10% Travel
To find out more about Real please visit www.realstaffing.com