Senior Hardware Test Engineer
A medical device company in Sunnyvale, CA is currently searching for a Senior Hardware Test Engineer supporting molecular diagnostics equipment. We need your valuable broad spectrum of experience as part of the hardware sustaining engineering team. The primary responsibilities will be leading the transition of production to contract manufacturer. This includes directing manufacturing efforts and resolving issues and implementing efficient and cost-effective methods. The role involves working side-by-side with Electrical, Manufacturing, and Mechanical Hardware Engineers improving, and implementing product & process improvements within our operations and integrating new solutions into the production environment. Specifically the individual will design, develop, and validate test methods and protocols for performance verification and validation of hardware and consumables designs, including IQ/OQ/PQ activities as necessary, and will execute testing, perform data analysis, and provide feedback to the team regarding system performance relative to defined metrics.
The individual is responsible for the quality of hardware product designs. Most importantly, the candidate exhibits the desire and ability to collaborate and excel in teamwork and communication, be able to work independently with minimum guidance. This role will interface with all levels of the company and collaborates with engineering, SW, marketing, manufacturing, quality, purchasing, regulatory, service, and contract manufacturer as well as other cross-functional teams.
- Lead Manufacturing transition project, including prepare plan, schedule. Coordinate with all stakeholders and ensure timely product transfer completion.
- Prepare, identify, setup, and validate IQ/OQ/PQ test assembly in preparation of transition into volume production
- Document findings in detail report, and present findings to cross functional Core team.
- Develop and document manufacturing processes
- Prepare product BOM based on source information
- Strong technical background in electrical test, and optics fundamentals, particularly in electrical functional test, and optical measurement techniques.
- Develop measurement methods and equipment that are repeatable, reproducible, and automated as appropriate to enable thorough validation coverage on tight development and production schedules.
- Applies multiple engineering disciplines to plan, organize and conduct technical projects within design, fabrication, modification and evaluation of new or enhanced hardware test. Projects may involve exploration of products and/or process problems, definition and selection of new concepts and approaches, origination or modification of material, component and process specifications and requirements.
- Independently research solutions, troubleshoot and resolve complex engineering problems by analyzing existing product issues and performance. Analyzes data, conducts experimental tests and evaluates results.
- Liaise with Operations to support internal test equipment and programs to ensure the continuity of product flow and quality.
Must demonstrate leadership skill, drive, and self-initiative to deliver clear business outcome.
Bachelor's degree with 5+ years of related work experience OR Master’s degree in the field with 3+ years of related work experience.
Fields of Electrical Engineering preferred, Industrial Engineering, Optical Science, Biomedical Engineering, Bioengineering, Mechanical Engineering, Materials Science, or a related field.
Knowledge and Skills:
Experience designing, validating, executing, and documenting test methods and protocols, including IQ/OQ/PQ testing and Design Verification testing
Hands-on experience building and testing hardware (mechanical, optical, electrical) instrumentation, consumables, and systems
Program Management experience to work with contract manufacturer
Experience in contract manufacturer product transfer, and medical/Biotech industry.
Data Handling - experience on how to organize and store a high volume of data
Experience with C, C++
Experience with software design and development
Root cause failure analysis and hands-on troubleshooting
Knowledge of electrical systems and apparatus, such as electric motors, sensors, LED, machinery controls, PCBA, cable harness, touch screen, LCD, battery, printer, and scanner.
Clear and concise technical writing for the documentation of experiments and test reports
Excellent verbal and written communication skills
Independently manage day-to-day project activities, multi-tasking to support concurrent projects
Effectively communicate with a wide variety of people and departments within the company
Data analysis using MiniTab, Origin, Mathematica, Matlab, or equivalent software. Experience with basic statistics.
Knowledge of optics and optical systems
Knowledge of Agile, medical regulatory process
Knowledge of IEC 60601, 61010, and 61326 standards
Experience with medical device systems
Detailed knowledge of Design Control processes
Electrical design and analysis skills including circuit design, troubleshooting and current electronic manufacturing process controls.
Bachelor's degree with 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience
Ability to work in an office environment
Travel as required.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.