- Support internal and/or external design activities to support development of new technologies and complete functional systems including manufacturing processes.
- Prepare schematics, simulations, prototypes, PCB layouts, specifications, bills of materials, assembly drawings, and other documents as required to manufacture or support product.
- Develop, implement characterization and/or design verification strategies for existing and new designs.
- Prepare and/or review design change requests including V&V activities supporting design changes.
- Perform analysis of designs for risk, hazard, test, assembly, manufacturability, etc.
- Contribute to the IP landscape via invention disclosures, disclosure expansion, and patent filings.
- Support Manufacturing and root cause analysis of product failures as required.
- Adhere to Lungpacer’s QMS including design control policies to ensure product quality.
- Perform technical writing and develop/deliver presentations as required.
- Bachelor’s in Electrical Engineering or related field.
- 3+ years of related experience OR Master’s degree in Engineering and 1+ years related experience.
- Demonstrated experience in both analog and digital electronic design/development that includes use of microcontrollers. Embedded software experience a plus.
- Ability to create limited SW applications (e.g., Lab View) a plus.
- Ability to design and implement FPGA logic in VHDL is preferred.
- Demonstrated experience with design test creation and execution. EMC / EMI compliance testing experience a plus.
- Familiarization with and practical knowledge of simulation tools.
- Strong knowledge of FDA Design Controls / ISO13485 / EU MDR and medical device product development is preferred.
- Familiarization with IEC60601, IEC62304, and ISO14971 is preferred.
- Strong knowledge and demonstrated successes in the development of complete medical systems including electronics and software is preferred.
- Excellent interpersonal and communication (both oral and written) skills.
This role is expected to work independently with minimal supervision, under the direction and support of Systems Manager.
The incumbent will work from the corporate office located in Exton, PA.