Hardware Test Engineer
Hardware Test Engineer
AliveCor, the creator of the Kardia Mobile ECG app, seeks a Hardware Test Engineer to join an exciting start-up that is changing the face of mobile health. As the Hardware Test Engineer, you will be a crucial member of hardware R&D team responsible for ensuring that AliveCor products perform as intended and meet/exceed customer expectations. You will work closely with our Quality, Regulatory, Software Engineering, Product Management, and Creative teams to ensure new products perform as intended while fully documenting the verification process. You will also work with our manufacturing team to implement and support manufacturing test fixtures. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you.
- Product manufacturing support:
- Develop and support automated test fixtures for PCBA level and Finished Good testing
- Support and optimize manufacturing processes
- Create and maintain test documentation for ISO 13485 quality system
- Support validation testing of changes in manufacturing
- Perform root cause investigations of failures and returns and drive corrective actions
- Assist new product development:
- Verification and validation testing for product hardware, process, packaging, etc.
- Support regulatory testing for FDA submissions under ISO 60601 standards for safety and essential performance
- Testing competing ideas of a design element to determine the best solution to meet requirements
- Evaluate new products and integrated solutions for product development
Qualifications and Skills:
- BS in Electrical Engineering or equivalent educational experience pertaining to technical writing, scientific method, and problem solving
- Experience working with quality systems in a regulated environment (e.g., medical device, pharmaceutical, aerospace, etc.)
- Ability to manage small projects: organized, independent, and results oriented.
- Superb analytical and diagnostic skills. Must have strong statistical analysis skills.
- Excellent communication skills, strong team ethic, and attention to detail
- 1-5 years’ experience in ISO 13485 medical device manufacturing.
- Process-oriented thinking
- Experience in communicating with users, other technical teams, and management to collect product information, investigate product or process issues, conduct robust risk assessments, etc
- Demonstrated competence documenting technical information and communicating it to others.
AliveCor is located in downtown Mountain View, CA. We are close to Caltrain and supply car and bike parking for employees. We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.
- Competitive salary and competitive stock options
- Flexible and generous vacation policy
- Maternity / Paternity Leave
- TriNet medical coverage, employee 100% covered for medical, dental and vision
- Equipment allowance to build out your ideal workspace
- Mobile reimbursement
- Stocked kitchen + weekly catered lunches
- A supportive, collaborative group of people who understand that success depends on the team
A supportive, collaborative group of people who understand that success depends on the team
AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.