Electrical Engineer

  •  

Boulder, CO

Industry: IT Consulting/Services

  •  

5 - 7 years

Posted 297 days ago

  by    Cynet EngineeringTeam

This job is no longer available.

We are looking for Electrical Engineer for our client in ?????Boulder, CO

Job Title: ????Electrical Engineer

Job Location: ???Boulder, CO

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Min 5year of exp

Overview:

  • The sustaining engineer?s primary responsibility will be to support Patient Monitoring products currently on the market. 
  • The sustaining engineer will solve design, quality and component issues, provide technical support for field issues and process issues, and validate components, materials and applications while sustaining current product designs. 
  • The engineer is responsible for the medical device design history files, determining test requirements and coordinating verification and validation testing. 
  • In addition, the sustaining engineer will support design changes to ensure regulatory compliance to current and new international and national standards and regulations, perform complaint investigations, and perform root cause failure investigations. 

Primary Skills:

  • 6+ years of experience working in a multifaceted environment with internal and external customers in a technical support role. 
  • Hands on in the lab experience, ability to design circuits, some type of regulatory experience
  • Provides technical support for existing products by developing solutions for complex issues with relatively high organizational impact and with a high level of accountability and minimal supervisory oversight.
  • Maintains products throughout their lifecycle by updating designs and design documentation to the latest national and international standards.
  • Performs and validates design changes to PCBA, power supply, battery, display, and electro-mechanical systems due to component obsolescence.
  • Establishes a wireless core competency which includes both established and state-of-the-art wireless methodologies as well as an in-depth understanding of standards and use cases to support remote monitoring products.
  • Serves as a mentor and technical leader for less experienced engineers and technicians within the Sustaining Engineering group.
  • Maintains product performance and quality by leading or assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as: 
  • Non-conformance investigation and root cause analysis 
  • CAPA resolution 
  • Regulatory compliance 
  • Product Design Verification and Design Validation 
  • Design changes 
  • Test methods and tooling design 
  • Process enhancement and improvement
  • Updates and documents components, modules and assemblies for RoHS and REACH compliance.
  • Follows strict adherence to policies and procedures associated with an FDA controlled environment.
  • Works with clinician?s technical issues and communicates solutions at the appropriate level.
  • Integrates product performance activities with new product development to improve project delivery time and reduce post release production issues. 
  • Sustaining engineering RoHS programs, product design and project management experience.
  • Demonstrated experience and a proven track record of success in product support evidenced by lowered support or warranty costs and by a failure rate reduction
  • Experience with internal and outsourced sustaining development projects
  • Proven ability to partner cross functional organizations to successfully drive the business (relationship building skills is key ? influencing ? working through people)
  • Solid working knowledge of quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (e.g. FDA, ISO, ANSI, HIMA)
  • Must be a strong communicator, verbal and written, across all levels of the organization as well as cross functionally
  • Must be an extensive multi-tasker, and problem solver with high energy levels and strong organizational abilities. Must be organized and attentive to details, and must have strategic and tactical thinking.
  • Medical Device and clinical environment experience
  • software and scriptingexperience is a plus (C, C++, Matlab, Python, etc.)

Secondary Skills:

  • Experience with international teams and Contract Manufacturers Globally.
  • communicate with peers and co-workers
  • Travel expectation is 10-15% globally.

Educational Qualifications:

  • BSEE with Electro/mechanicalexperience and product life cycles