Job Description
Summary: Seeking an experienced Electrical Engineer with a strong background in the medical device industry, specializing in capital equipment design and proficient in various technical and engineering aspects.
Minimum Requirements:
- Bachelor’s degree in Electrical Engineering
- Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
- Strong knowledge of schematic design and layout using CAD tools for PCB design (e.g., OrCAD)
- Mastery in formal PCBA documentation
- Proficiency with basic laboratory instruments and tools (e.g., DMM, oscilloscope, logic analyzer, spectrum analyzer)
- Extensive experience in electrical system design, including design requirements, test requirements, procedures, and manufacturing
- Ability to understand design inputs and concepts, interpret detailed electrical specifications, and generate and review design documentation, test specifications, and test reports in compliance with medical device industry standards
- Skilled in leading the design, development, and implementation of manufacturing line transfers
- Proven ability to debug complex electrical systems within a manufacturing environment
- Support for day-to-day operations requests
- Leadership in conducting root cause investigations for manufacturing failures with cross-functional teams
- Technical assistance to departments such as Quality, Reliability, and Manufacturing
- Experience in executing experimental designs and analysis
- Ability to initiate and execute change management for design changes or part obsolescence
- Proficiency in detailed engineering analyses & documentation for design development and support process transfer
- Application and interpretation of characterization DOE models
- Utilization of technical skills in Six Sigma, Lean, DRM/DFSS, and other continuous improvement techniques
- Independent work ethic in consultation with Engineering Management
Nice to Have:
- Additional experience in the medical device industry and capital equipment design
- Experience with DRM methodology, statistical analysis tools (e.g., Minitab, JMP, Matlab), and technical documentation
- Direct experience in characterization, design of experiments, and data analysis methodologies
- Knowledge of medical device product development cycle and regulatory submissions
- Experience in supporting data submissions to governing bodies (e.g., FDA, cFDA, PMDA, LNE GMED)
- Proficiency in SolidWorks
- 5+ years in RF ablation generator design, embedded microcontroller/microprocessor system design
- Strong knowledge in analog and digital design
- Familiarity with Domestic and International standards for Ablation Generators
- Experience with engineering and manufacturing test equipment design, LabView, PCB fabrication and assembly, and writing embedded firmware (assembly/C/C++)
- Knowledge and experience in electromagnetic compatibility testing, electrical safety testing per IEC 60601, and hi-pot testing
Pay Details: $54.00 to $72.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.