Software Quality Engr II

Pay 40-60/h depending on experience

Responsibilities may include the following and other duties may be assigned.

Collaborate with cross-functional teams to evaluate product definition requirements.

Support new product development, mainly in updating and auditing Design History Files (DHF)

Support the remediation of design output documentation (e.g. software architecture documentation, software form and behavior specification) by ensuring they meet the intended use and performance criteria specified in the product requirements.

Identify potential design-related gaps due to remediation efforts and ensure that appropriate mitigation strategies are in place.

Assess test coverage is complete with regards to requirements and design outputs traced (including identifying gaps and unnecessary traces).

Document and report remediation results, providing clear insights and recommendations for future improvement.

Follow all Quality System Practices as defined by Medtronic Navigation's practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.

Top 3 technical skills that are required for the role:

1. Regulatory and compliance knowledge

2. software verification

3. soft skills: communication and teamwork, attention to detail, and a methodical approach to document review.

Education Required: Bachelor's Degree in Engineering, Science or technical field

Years' Experience Required: 4+years

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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