S-407 - SW Design Assurance Engineer

S-407 - SW Design Assurance Engineer

19 feb
|
Insulet Corporation
|
Tijuana

19 feb

Insulet Corporation

Tijuana

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.



We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!



Job Title: Software Design Quality Assurance Engineer



Department: Design Quality Assurance



FLSA Status: Exempt



SOP Group: Quality Assurance





Position Overview:

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices. This role will interface with other Insulet departments (e.g. Operations, and Information Technology, R & D, Testing, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development, and launched product support. 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:



- Support Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II medical devices, mobile applications, and cloud-based systems.

- Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.

- Provide guidance for the generation, review and approval of design control documentation with primary focus on software development deliverables.

- Support development teams on the validation of software tools.

- Support creation of necessary documentation to comply with regulatory requirements and industry best practices.

- Support Risk Management Activities for device systems in compliance with ISO14971 and software risk requirements in IEC 62304

- 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 Design Quality Assurance activities in software development.



Education and Experience:



- ASQ, CSQE or other software quality certificates are beneficial.

- BS degree, in an engineering/scientific/computer systems or quality management curriculum or equivalent experience. 

- Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and non-product Software Tools.

- Experience with software mobile applications, or cloud-based systems preferred.

- A minimum of 3 years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.

- Experience working with multi-site global development teams preferred. 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, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k).

- Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).

- Effective verbal and written communication skills.

- Experience with Agile Software Development principles preferred.

- Experience collaborating and communicating with individuals at multiple levels in an organization.

- Ability to prioritize and manage key deliverables in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.

- Able to work effectively in a dynamic, high-energy environment.



Travel:



- Occasional travel to the San Diego office as necessary to support project activities.



Posted 30+ Days Ago



Full time



REQ-2020-1335



About Us



Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.



Insulet is making significant investments in US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market that is exceeding customer expectations. Joining the Insulet team is a once in a lifetime opportunity to be a part of an amazing company with remarkable people guided by shared values.We are interested in motivated performance driven individuals who are ready to take on new opportunities to enhance their career and be a part of our fast-growing organization.



Insulet is proud to be an equal opportunity workplace. Individuals seeking employment at Insulet are considered without regards to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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