Job Description

Akkodis is seeking a Embedded Software Engineer for a 6+ Contract position with a client located in Maple Grove, MN

Pay Range: $50/hr - $60/hr ( The rate may vary based on experience, education, geographic location, and other factors. )

Position Responsibilities

Develops, establishes, and maintains software quality assurance methodologies, systems, and practices that meet customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Provides focused software quality assurance support within new product development, operational, or system/services support.

Your Responsibilities Will Include:

• Working within a team of Software Engineers that support embedded R&D systems in the Peripheral Interventions division.
• Actively contributing to all aspects of Software Quality Assurance activities in an FDA-regulated medical device environment and ensuring that software verification and validation is carried out in compliance with site/corporate policies and procedures.
• Performing independent reviews of design, development, and testing of software/firmware used in Peripheral Interventions product lines throughout their entire System Development Life Cycle.
• Reviewing and approving documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix, and qualification reports along with support documentation for equipment qualification.
• Reviewing and approving changes to existing systems from a Software QA perspective, ensuring changes are implemented in compliance with internal procedures and external standards.
• Reviewing test results for GDP compliance and ensuring that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.
• Ensuring that best software QA practices are employed by all departments so that software/firmware-based systems are developed, qualified, and maintained in a manner that provides assurance the system conforms to both internal and external requirements.
• Supporting site audits, non-conforming events, and CAPAs as required.

Required Qualifications:

• Bachelor’s level degree or higher in Science/Engineering/Software discipline.
• Minimum of 2 years of related work experience in Software QA and/or computer systems validation.
• Knowledge of the System Development Life Cycle (SDLC), preferably with automated manufacturing and computerized lab systems.
• Understanding of 21 CFR Part 11 (electronic records/electronic signature).
• Experience supporting manufacturing in regulated industry.

If you are interested in this Embedded Software Engineer job in Maple Grove, MN, then please click APPLY NOW. For other opportunities available at Akkodis go to . If you have questions about the position, please contact Sunny Kumar at [email protected].

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

The Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance

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