Job Description
Job Description
Job Purpose
The Senior Electrical Engineer is an integral member of the electrical team within the R&D department. This position supports electronic design and development for new and existing products ranging from simple to complex electronic systems such as PCB board, system wiring, and electro-mechanical development.
Essential Functions and Basic Duties
- Develop complex electronic designs and maintain existing products using design control processes and procedures in accordance with the FDA design control guidelines established for type 2 and type 3 medical devices.
- Be a contributing resource for team project planning, prioritization, resource management and completion of deliverables.
- Lead initiatives and collaborates with cross-functional team members to support tasks such as part changes, product enhancements, and test fixture qualifications.
- Develop and maintain technical documents such as design input requirements, test protocols, and reports.
- Provide technical guidance and act as a mentor to team members as needed.
- Other duties as assigned.
- Adheres to all company policies, procedures, and business ethics codes.
Qualifications
- A bachelor's degree in electrical engineering, master’s degree preferred.
- Minimum 5 years of electronic engineering design and development experience. Critical care medical devices preferred.
- Minimum of 5 years of design experience using electronic CAD software packages.
- Experience with the development and performance of verification and validation testing required for high reliability critical care devices.
- Experience in FMEA design requirements for critical care devices.
- Capable of analyzing and solving complex problems and making decisions based on data analysis.
- Experience working with suppliers of electronic components, subassemblies and finished devices.
- Ability to perform root cause analysis and recommendations for non-conforming products.
- Excellent listening, verbal communication, and technical writing skills.
Preferred Qualifications
- Electronic design experience of IPC class 3 critical devices.
- Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices.
Working conditions
- Works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.
- Works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
Physical Requirements
Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone.
Must be able to lift and carry up to 50 lbs.
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