Sr. Systems Verification and Validation Engineer (Minneapolis/Hybrid) (Engineering)

About Mozarc Medical

At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.

Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.

Position Title: Sr. Systems Verification and Validation Engineer

Location: Minneapolis, MN USA. Hybrid or in office.

 

A Day in the Life

As a Senior Systems V&V Engineer, you will play a key role in ensuring that our complex dialysis systems meet design requirements and satisfy stakeholder needs. You will be an integral part of the product development process, driving innovation and efficiency across the development lifecycle through automation, continuous integration, iterative design verification, and stakeholder-focused validation.

Responsibilities

• Own V&V Strategies: Define and execute test strategies for system-level, integration, and component-level testing, including hardware, software, and firmware. Lead the end-to-end verification process to demonstrate that products meet all requirements. Establish automated testing strategies that minimize manual testing efforts.
• Deliver V&V Documentation: Develop and maintain comprehensive V&V documentation, including but not limited to verification plans, verification protocols and reports, test method validations, traceability matrices, and risk assessments. Provide regular updates and communicate progress, findings, and recommendations to cross-functional teams, stakeholders, and management.
• Process Innovation: Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the verification and validation process. Stay updated on emerging technologies, best practices, and regulatory changes to ensure the highest standards of compliance and innovation.
• Requirements and Product Development: Work with engineering, marketing, quality, and project management teams to develop, decompose, and review product requirements. Ensure early integration of verification inputs such as test standards, regulations, and industry conventions.
• Continuous Product Improvement: Effectively communicate and present findings, problems, and solutions within the organization, including recommendations for actions and prioritization. Analyze and interpret test data, identify issues, and drive resolution through root cause analysis and corrective actions. Drive prioritization of product improvements based on testing data and analysis of ongoing issues.
• Data Analysis and Statistical Tools: Utilize statistical tools such as DOE, ANOVA, T-Test, and capability analysis to analyze product performance, guide decision-making, and support verification and validation activities.
• Regulatory and Standards Compliance: Participate in safety risk management activities following ISO 14971 standards. Ensure compliance with all relevant test standards (IEC 60601-1), regulations, and industry conventions from early design phases through product launch.

Must Have

Bachelor's degree n an engineering field and minimum of 4 years of relevant experience, or advanced degree in an engineering field with a minimum of 2 years relevant experience.

Nice to Have

• Experience working in the medical device industry developing products under ISO 13485 and FDA regulations.
• Product development experience working in an Agile/iterative environment utilizing continuous integration.
• Experience with complex, electro-mechanical, software-controlled systems, particularly      dialysis systems.
• Awareness of medical device standards including IEC 60601-1, ISO 14971, IEC 62304
• Experience with database-based requirement, risk and verification tools such as Jama Connect, Siemens Polarion, or PTC Codebeamer used to create, review, and trace all product development content.
• Previous utilization of issue tracking tools such as JIRA.
• Code based data analysis skills using Python, Matlab, or other similar languages
• Ability to develop testing dashboards and product performance reports leveraging Snowflake, Fabric, or other similar databases.
• Labview based test equipment development experience. Either directly developing these systems or working with external partners to deliver equipment which reduces manual testing effort.

• Solid understanding of Design Controls, Medical Device Design Verification, Medical Device Design Validation, and GDP (Good Documentation Practices)

• Experience with clinical validation or working on medical devices requiring clinical use.
   

Why Work with Us? 

Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life. 

It's essential our team members feel valued, supported and empowered too. That's why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.

Ability To Travel

Ability to travel 10%, including internationally.

Physical Job Requirements 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.