Manager, Software Test Engineering (Hybrid - San Diego, CA)

Insulet Corporation-posted about 1 month ago
Full-time • Manager
Hybrid • San Diego, CA
1,001-5,000 employees
Miscellaneous Manufacturing
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This position is responsible for Software Test Manger leading software test activities throughout the Software Development Lifecycle for new product development and sustenance initiatives. This includes ensuring that the software test process and methodologies are compliant with applicable standards, regulations and software test guidance for medical devices. This role will interface with other Insulet departments (e.g. Software Development, System Engineering, Hardware team, Manufacturing, Quality assurance and Regulatory Affairs) as well as other external parties on issues related to product development, launch and product support. The ability to effectively communicate software test design development, applicable regulations, optimize the verification process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position. This position also includes direct reports.

  • Manage the software testing team and ensure Software verification is conducted in accordance with the FDA standards to deliver high quality software.
  • Manage a team of 4-8 software application Manual/SDET test engineers.
  • Mange Design Control and Software Test initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices.
  • Responsible for the generation, review and approval of design control documentation with primary focus on software test deliverables.
  • Collaborate with Project Management to support and optimize the schedules.
  • Support software development teams on the validation of software tools.
  • Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements.
  • Lead the creation of necessary documentation to comply with regulatory requirements and industry best practices.
  • Establish and maintain software test programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
  • Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
  • Provide guidance and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management, review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
  • Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to software test activities in software development.
  • Work closely with the software development team to identify improvements.
  • Influence the requirements definition and software design to maximize testability.
  • Oversee and influence development of test objects to meet needs of protocol.
  • Develop and extend protocols and plans as device features evolve.
  • Participate in product design reviews.
  • Represent software test in the core team meetings.
  • Creating and executing test plans, test designs and test cases and generating test reports.
  • Creating and updating Trace matrices between requirements and Tests.
  • Work with the scrum Master and product owners to prioritize or deprioritize the backlog.
  • Keep track of the Testing board and tools inventory for the team.
  • Performs other duties as required.
  • Effective verbal and written communication skills.
  • Working knowledge of software testing tools.
  • Able to communicate at multiple levels of an organization.
  • Deep knowledge of software testing (Manual, Automation and code Inspection)
  • Software test group experience strongly preferred.
  • Strong written, verbal, interpersonal and presentation skills
  • Bachelor's degree required (preferred field of study: Software Engineering, Computer Science); 6-8 years hands on experience in software testing in regulated industry and/or equivalent combination of education and experience.
  • Experience of 3+ years being the Software Test Lead/Manager.
  • Thorough understanding of software test principles, practices and metrics as well as software development and testing best practices that foster high quality software.
  • Hands on experience using modern software development and software test tools.
  • Proven record developing and executing software test protocols for complex medical devices.
  • Familiarity with IEC 62304, ISO 14971, FDA regulations and international standards applicable to medical device software development, verification and validation a plus.
  • Experience working with products from the prototype through 510(k)/ISO clearance and commercialization is preferred.
  • Self-motivated
  • Proactive
  • Quick learner
  • Mentor
  • Ability to represent the team cross functionally.
  • Generate metrics for the team as required.
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)
  • And additional employee wellness programs
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