Sr. Hardware Electical Engineer

1 month ago

Milpitas, United States Stellartech Research Corporation Full time
Job DescriptionJob Description

About Stellartech Research Corporation (SRC)

SRC develops medical devices for client companies, from small start-ups to the largest medical device operations. Although SRC provides contract manufacturing services, our operation is fundamentally different from a typical “CM”. SRC is a medical technology development engine; we provide design expertise and maintain a deep understanding of tissue treatments using a variety of therapeutic energy delivery means. Since our founding in 1988, SRC developed dozens of systems for client companies serving a wide range of medical applications. Our teams have developed devices to deliver x-rays, RF and microwaves, cryogen, ultrasound, steam, pulsed electric fields, and more for treatments including cancer, cardiac arrhythmia, hypertension, chronic pain, cosmetic applications, and many others.

As a relatively small company (~130 employees), we have an out-sized impact on medical devices. One such example is a system for treatment for pre-cancer of the esophagus (Barret’s) which proved to be highly safe and effective and changed the standard of care in the field. The initial product was conceived and developed entirely within SRC, and our staff are named inventors of the technology. The product (Barrx) maintains majority market share (recently estimated > 90%), and was purchased in 2012 by Covidien/Medtronic.

SRC offers the opportunity for each team member to make significant contributions to the products we develop. Most of our staff are on a first-name basis, and we have an unusually large number of employees who have chosen to stay with our team for over 10 years despite their very marketable skills. At SRC, one can expect to be depended upon and trusted to deliver work output worthy of our reputation. In our relatively small operation, our responsibilities are broad and we are given significant latitude. As a privately-held, employee-owned company we are in control of our destiny and share responsibility for each other’s welfare. We provide a full array of competitive benefits and compensation to our employees.

ESSENTIAL FUNCTIONS:

1. Design, develop, and document electronic hardware for medical device systems that include an embedded microprocessor running a real time operating system, as well as User Input devices, including touch panel displays, and various signal input and output interfaces

2. Must be capable of circuit design, generating schematics and performing board layouts, creating board assembly documentation and working with board houses to supply finished boards.

3. Work with board houses to specify and implement automated board test protocol and harness assembly testing.

4. Specify procedures and fixtures to test electronic medical device

5, Assist manufacturing in prototype and pilot builds of electronic medical devices. Serve as the lead technical resource for NPI product builds

6. Assist manufacturing in hardware problem analysis and solutions

7. Assist in training of technicians and manufacturing staff on new products and procedures

8. Prepare design verification and validation protocols for electronic medical devices

9. Perform design verification and validation studies

10. Participate in design reviews for electronic medical devices

11. Familiarity with Electrical Safety Certification processes and the 60601 consensus standards.

12. Participate in FMEA and risk management reviews for electronic medical devices

13. Perform product safety testing for regulatory submissions

14. Evaluate and select development tools and equipment


EDUCATION AND EXPERIENCE:

Typically requires a BSEE or equivalent. MS degree is preferred. At least 12+ years of experience or a BS/MS with 9+ years’ experience is required. Medical Device experience is desired.

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