Careers in MedTech

Job Title

Software Quality Engineer I/II/Sr.

Company

Experien Group

Description

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implants, single use disposables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.

We are seeking a Software Quality Engineer to support our senior Quality team. The Software Quality Engineer will organize and manage the Quality activities for clients to help identify and meet Quality Management System (QMS) needs. Additionally, the Software Quality Engineer will evaluate Design Outputs and Design Changes for quality requirements, work with clients to assure quality, risk, or other management plans for equipment and processes for general and specific product performance needs are established according to the client’s QMS. These activities must be in accordance with industry standards and testing including as applicable, FDA Quality System Regulation, ISO 13485, ISO 14971, ISO 62304, ISO 82304 and the EU Medical Devices Regulation.

This position requires that you work in our San Jose office.

MAJOR DUTIES OF POSITION:

  • Administer Device Design and Change Control and perform quality engineering activities. This will include working with clients to assure Design Control and Design Change activities are completed correctly and in a timely manner. Including assisting them with development and reviewing software lifecycle management documentation.
  • Work with cross-functional teams to assure adequate testing strategies are developed and verification and validation plans are executed according to established schedules and procedures, including reviewing test protocols and reports for completeness and compliance.
  • Work with development engineers, product marketing, and project management to assure product/software requirements are documented traceable to testing and design outputs in the software design specification(s).
  • Support design team in performing and properly documenting development activities such as requirements analysis, use case development, and risk management performed to ensure that the device verification and validation is complete, the product is safe and of high quality, and that the quality system documentation as well as the product meet all regulatory requirements.
  • Support software maintenance, including software patches and software updates to verify that all appropriate documentation is established, reviewed and revised appropriately, including assuring new features have been properly specified and tested and regression testing of devices has been performed to assure continued safety and effectiveness after changes have been implemented.
  • Maintain accountability for project timelines and deliverables to both internal and external stakeholders.
  • Support other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations to assure these activities are performed and documented correctly and in a timely manner according to the client’s established QMS.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Bachelor degree in Engineering or Life Sciences required.
  • Minimum 2 years’ experience with medical device companies whose products contain or are software for Quality Software Engineer I/II
  • Minimum 4 years’ experience with medical device companies whose products contain or are software for Senior Quality Software Engineer
  • High attention to detail and time management skills for self and others required .
  • Working knowledge of medical device regulations and standards (i.e., QS Regulation, ISO 13485, ISO 14971 series, ISO 62304, and ISO 82304,) required.
  • Experience with additional medical device regulations including ISO 60601 series, ISO 62366 series, ISO 10993 series, ISO 11135, and ISO 11137 desired.
  • Understanding of the full product life cycle for a medical device and an understanding of the differences between product lifecycles for traditional PEMs devices vs SaMD..
  • Strong computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms is a plus.
  • Experience with automation testing frameworks such as Selenium, Webdriver, TestNG is a plus.
  • Understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product maintenance required.
  • Excellent verbal and writing skills including the ability to make others achieve deadlines and required commitments is required.

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.

Published
September 28, 2021
Location
San Jose, CA
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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