AlisoViejoRecruiter Since 2001
the smart solution for Aliso Viejo jobs

Engineer II, Software Validation

Company: MicroVention-Terumo
Location: Aliso Viejo
Posted on: February 22, 2021

Job Description:

INNOVATION STARTS WITH YOUAre you interested in working for an organization that is making a difference in people's lives every day?--We're a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease.--We're a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data.--Take a closer look at what MicroVention-- TERUMO--has to offer.The Software Validation Engineer develops/executes strategies and procedures for Software validation. Manages the Software Lifecycle program. Job duties:* Develops strategies for continuous improvement to the SW lifecycle program, to ensure improved compliance to regulations (i.e. identify which procedures are required, high level summary of the required sequence of events, etc.)* Generates Master Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc.* Develops SW validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements. This includes, but is not limited to, SOPs, forms, SW categorization procedures, risk assessment procedures, change control documents, etc.* Manages completion of projects per SW validation master plans and ensures timely completion. Maintains frequent communication with stakeholders and manager regarding project status.* Derives solutions to challenges and escalates any issues as they are identified.* Works with software owners to generate and maintain master SW list(s).* Provides expertise to SW owners with regards to identifying required level of validation for SW items.* Reviews and approves SW validation protocols and reports (verifies test cases are adequate, verifies executed protocols for GDP, etc.)* Ensures software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.* Performs other duties and responsibilities as assigned.Qualifications:- Bachelor's degree in IT, Engineering or other relevant discipline or equivalent experience.- Minimum three (3) or more years of experience in project management.- Minimum three (3) or more years of experience validating software applications.- Minimum three (3) or more years of experience in medical device software. regulations, including involvement with electronic records and electronic signatures.- Successfully manage/execute large projects with the ability to motivate cross-functional teams to complete their assigned tasks.- Demonstrated experience in medical device manufacturing SW and Quality Management SW.- Demonstrated experience in medical product quality assurance.- Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.- Demonstrated skills in project management.- Successful experience working with others on software application projects.- Successful experience working independently, effectively and confidently in a team environment.- Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).- Working knowledge of AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.- Working knowledge of Guidance for Industry, FDA Reviewers and Compliance on OTS SW Use in Medical Devices.Desired Qualifications- Ability to work with multiple associates and prioritize projects to meet deadlines.- Ability to present SW validation strategies and obtain alignment from stakeholders (i.e. upper management).- Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.- Ability to translate regulation requirements into practical validation plans.- Ability to write, review, and approve SW validation protocols and reports.- Ability to determine the required test cases during SW validation.- PMP certification desired, but not required.- Excellent written and verbal communication skills.- Proficient with MS Project, Word, Excel, Outlook.Additional Information* Must be eligible to work in the United States with no visa sponsorship requirement.* Relocation available for qualified candidates.* For more information, visit our web site at--www.microvention.com

Keywords: MicroVention-Terumo, Aliso Viejo , Engineer II, Software Validation, IT / Software / Systems , Aliso Viejo, California

Click here to apply!

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

I'm looking for
in category
within


Other IT / Software / Systems Jobs


In-Home Usage Tester (Product Tester from home) Part-time
Description: American Consumer Panels reg , located at One World Trade Center, 285 Fulton St., Suite 8500 New York, NY, 10007, is looking to fill the position listed below nationwide : br br In-Home Usage Tester (more...)
Company: American Consumer Panels
Location: Cerritos
Posted on: 02/28/2021

Sr. Oracle Financial Functional Analyst
Description: The IT Finance Systems Functional II will work within the IT Team to support the overall system/ network needs of Niagara's corporate office and plants.Work with Finance business process owners and relevant (more...)
Company: Niagara Bottling LLC
Location: Diamond Bar
Posted on: 02/28/2021

Lead I - Software Testing
Description: Role Proficiency: Level of Proficiency: Ensuring adherence to test practices and process to improve test coverage Outcomes: 1. Create Test Estimates and Schedules 2. Identify business processes, conduct (more...)
Company: UST
Location: Cerritos
Posted on: 02/28/2021


Technology Lead - .NET (Only US Citizen & GC can Apply)
Description: Technology Lead - .NET Only US Citizen GC can Apply ul li Rosemead, CA li Full-time Job Description Hi, br br I hope you are doing good. br br I have a job opportunity related to your (more...)
Company: EAD Corporations
Location: Rosemead
Posted on: 02/28/2021

Lead Software Engineer
Description: Our Zigzy family is filled with some of the most amazing product, engineering, sales, and marketing people around. We can't wait to meet you Competitive health packages to keep you healthy and happy. (more...)
Company: Regional Recreation Corporation of Wood Buffalo
Location: Tustin
Posted on: 02/28/2021

Entry Level Software Developer
Description: Revature is the fastest growing employer of emerging technology talent. We will hire over 300 Entry Level Software Developers across the country in the next 4 weeks.One day someone is going to ask you (more...)
Company: Revature
Location: Cypress
Posted on: 02/28/2021

Technical Support Lead
Description: We are focused on the health and safety of our workforce, clients, and greater community. Our team is working hard remotely to support your staffing and job search needs. Please call us at 1-503-299-6811 (more...)
Company: VanderHouwen
Location: Newport Beach
Posted on: 02/28/2021

Senior Software Engineer, AI
Description: Who We AreAt Visual Concepts, we believe great games are made by diverse and empowered teams with a shared passion for play. As one of the world's top game development studios, we have shipped over 100 (more...)
Company: Visual Concepts
Location: Lake Forest
Posted on: 02/28/2021

Product Tester (from home) - Part-Time, No Exp Req. $25-$45/hr
Description: American Consumer Panels reg , located at One World Trade Center, 285 Fulton St., Suite 8500 New York, NY, 10007, is looking to fill the position listed below nationwide : br br In-Home Usage Tester (more...)
Company: American Consumer Panels
Location: Aliso Viejo
Posted on: 02/28/2021

Lead Java Developer
Description: We strive to have our business and services
Company: Motion Recruitment Partners LLC
Location: Lake Forest
Posted on: 02/28/2021

Log In or Create An Account

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

Aliso Viejo RSS job feeds