SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Sr. Software Design Quality Assurance Engineer

Company: Insulet Corporation
Location: San Diego
Posted on: June 15, 2019

Job Description:

Position SummaryThis position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. This role will interface with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system. The ability to effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.Responsibilities

  • ASQ, CSQE or other software quality certificates are beneficial.
  • BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master's degree preferred.
  • Experience with medical device software development.
  • Experience with a risk-based approach to validate computerized systems, Commercial off the Shelf (COTS) software and SW Tools.
  • Experience with software mobile applications, cloud based systems, and cybersecurity.
  • A minimum of 10 years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • Experience in the development and implementation of effective Design Control Systems.
  • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
  • Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for PMA and 510(k).
  • Demonstrated experience organizing and maintaining large documentation sets.
  • Experience with structured phase-gate product development processes.
  • Familiarity with GAMP 5 guidance.
  • Experience with software design V&V, computerized systems validations, and process validations.
  • Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
  • Experience with software development lifecycles with emphasis on the software quality engineering aspects.

    Education and Experience

    • Effective verbal and written communication skills.
    • Experience collaborating and communicate with individuals at multiple levels in an

    • Ability to prioritize and manage critical project timelines in a fast paced environment. Must be able to handle multiple responsibilities concurrently.

    • Strong analytical and problem solving skills.
    • Able to work effectively in a high-stress, high-energy environment.
    • Ability to manage people and projects in a fast moving environment.

Keywords: Insulet Corporation, San Diego , Sr. Software Design Quality Assurance Engineer, IT / Software / Systems , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other IT / Software / Systems Jobs

Lead Java Developer
Description: Position Java Lead Location San Diego, CA Duration Long Term Contract JOB DESCRIPTION Expertise with the following Java, J2EE etc Open source frameworks and
Company: InfiCare Technologies
Location: San Diego
Posted on: 06/27/2019

Senior Software Engineer
Description: Greetings from Apollo Technology Solutions Please share your resumes to Title Sr. Software Engineer Client State Clients Location San Diego, CA Job Description Qualifications 8 years experience writing (more...)
Company: Apollo Technology Solutions
Location: San Diego
Posted on: 06/27/2019

Senior Azure Developer
Description: VDart is an IT staffing firm based out of Atlanta, GA specializing in Digital Emerging technologies. Founded in 2007, VDart has over 1700 employees and contractors spread across 3 continents. We specialize (more...)
Company: VDart, Inc.
Location: Encinitas
Posted on: 06/27/2019

Sr Java Developer-lead
Description: Looking for Java Lead San Diego, CA for long term project Expertise with the following Java, J2EE etc Open source frameworks and tools such
Company: Profile500 Corporation
Location: San Diego
Posted on: 06/27/2019

Applications Programmer 2
Description: 98920 APPLICATIONS PROGRAMMER 2 br br Extended Review Date: Fri 6/21/2019 br br This is a 50 - 100 career position with full medical and retirement benefits. br br This position will remain (more...)
Company: University of California - San Diego
Location: San Diego
Posted on: 06/27/2019

Senior Linux Systems Administrator
Description: Job Description: br br The Leidos Innovations Center LInC at Leidos currently has an opening for a Systems Administrator to work in our San Diego, Ca office. This is an exciting opportunity to (more...)
Company: Leidos
Location: San Diego
Posted on: 06/27/2019

UI Developer
Description: Looking for UI Developer Job Location
Company: Profile500 Corporation
Location: San Diego
Posted on: 06/27/2019

Microsoft Dynamics CRM
Description: Microsoft Dynamics CRM Carlsbad, CA 6 months Job Responsibilities Experience in enhancing and customizing
Company: Innovative Information Technologies, Inc
Location: Carlsbad
Posted on: 06/27/2019

Lead Java developer
Description: 10 years of IT experience is mandatory for the role. Expertise with the following Java, J2EE, etc Open source frameworks and tools such as
Company: K Tek Resourcing LLC
Location: San Diego
Posted on: 06/27/2019

Senior Front End Developer (Remote)
Description: Senior Front-End Developer Remote HelloWe are looking for an experienced Front-End Web Developer to join our rapidly growing company. You will be working remotely as part of a cross-functional Agile (more...)
Company: CDM Technology
Location: San Diego
Posted on: 06/27/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds