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
- 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.
- 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.)
- Experience with international teams and Contract Manufacturers Globally.
- communicate with peers and co-workers
- Travel expectation is 10-15% globally.
- BSEE with Electro/mechanicalexperience and product life cycles