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Electrical Engineer III in Boulder, CO at APEX Systems

Date Posted: 2/13/2018

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Boulder, CO
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    2/13/2018

Job Description

Job #:  813225

Seeking a senior level Electrical Engineer with extensive experience in a regulated industry (FDA preferred, Aerospace, Military). Preferred experience includes circuit design, CAPA resolution, development projects, quality and regulatory requirements, ability to multi-task, root-cause investigations, and more. For immediate consideration, please send your updated resumes to zburrell@apexlifesciences.com

 

Must Haves:

  • Hands on in the lab experience
  • Ability to design circuits
  • Some type of regulatory experience (if not FDA, aerospace, military)

 

Possible temp to hire.

 

SUMMARY OF POSITION:

  • The sustaining engineers 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.

 

ESSENTIAL FUNCTIONS:

  • 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 clinicians 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.

 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

  • Prepares analysis reports for director(s), project leaders or other personnel.
  • Presents project status to management and teams, as required.
  • Develops and tracks work schedule and assignments.
  • Provides input to departmental planning and resource activities.
  • Other duties as assigned with or without accommodation.

 

Education:

  • BSEE with Electro/mechanical experience and product life cycles.

 

Experience:

  • 6+ years of experience working in a multifaceted environment with internal and external customers in a technical support role.
  • Sustaining engineering RoHS programs, product design and project management experience.

 

Preferred Skills/Qualifications:

  • 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

 

Skills/Competencies:

  • Problem solving, priority setting, customer focus and driving for results

 

Other Skills:

  • Must communicate effectively in English, both written and verbal
  • Some software and scripting experience is a plus (C, C++, Matlab, Python, etc.)

 

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

  • Partners closely with Global R&D Sustaining Engineering leaders Works on moderate to complex engineering tasks and provides weekly updates with their Supervisor.

 

WORKING CONDITIONS:

  • Normal office conditions and engineering labs Clinical Environment International travel to Design Centers, Manufacturing plants and Contract manufacturing facilities

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.