- 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.
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.
BSEE with Electro/mechanical experience and product life cycles.
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.
· 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.
Mid-level industry position
6135 Gunbarrel Ave, Boulder, CO 80301
Boulder , United States