Quality Engineer II at Stellartech Research Corp

Milpitas, California, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

130000.0

Posted On

27 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Design History File Documentation, Device Master Record Review, Process Validation, Internal Auditing, Verification And Validation, Hazard Assessment, FMEA, Risk Management, Regulatory Submissions, Device History Record Review, CAPA Investigations

Industry

Medical Equipment Manufacturing

Description

Description About Stellartech Founded in 1988, and headquartered in Milpitas, CA, Stellartech Research Corporation (SRC) is a world leader in the development of innovative devices for both large, established companies and early-stage start-ups in the medical industry. The medical systems we develop, and manufacture typically combine a complex electronic microprocessor-controlled device and a “smart” disposable. They employ cutting edge technology such as highly sophisticated energy delivery modalities, cloud-based wireless communication and advanced imaging capability. Our commitment to a “Multiphysics” approach and the mastery of the scientific principles necessary for design realization has allowed us to achieve medical breakthroughs and pioneer many “firsts” in the industry. These include the first temperature-controlled RF generator for cardiac ablation, the first monopolar capacitive RF tissue remodeling system for cosmetic use, and the first balloon-based system for esophageal ablation. With over 25 years of success, we’re continually developing new ideas to serve specialized markets in the medical industry. Position Summary Stellartech is seeking a Quality Engineer to support projects that will help the company continue our mission to deliver medical systems that advance the practice of medicine. This position reports to the Director of Design QA and will be an on-site position located in our Milpitas, CA facility. Requirements Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation. Review and approve Device Master Record documentation for new product design and maintenance, including bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator's manuals. Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary. Assist in process validation activities for new and current products. Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities. Assist Engineering in the preparation and execution of verification and validation protocols and verification and validation test reports for new products and changes to current products. Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products. Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies. Review and approve Device History Records for products finished device release as required. Serve as a technical resource for technicians, assemblers, and other Stellartech personnel. Perform other duties as Supervisor may direct. Education & Experience BS degree or equivalent. At least 1-3 years relevant experience is required. Participation in ASQ is desired. Salary Range: $110,000 – $130,000 annually. The posted range represents the company’s good-faith estimate of the base salary wage range the company reasonably expects to pay for this position upon hire. Actual compensation will be determined based on relevant factors such as skills, experience, education, and internal equity. Benefits: We offer a competitive benefits package to our full-time employees, including medical, dental vision, life and disability insurance, and paid time off. In addition, Stellartech offers a 401(k) plan with company match and a stock equity plan.

Responsibilities

The Quality Engineer will support new product designs by preparing design history files and reviewing device master records. They will also manage ongoing quality activities, including CAPA investigations, process validations, and regulatory submissions to the FDA.