Hybrid Senior Quality Engineer

at CVRx | Barostim

• Job title: Senior Quality Engineer
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Brooklyn Park, United States

About the role

• Senior Quality Engineer leading quality and reliability support for medical devices. Collaborating on product development and ensuring compliance with regulatory standards in the industry.

Responsibilities

• Lead quality and reliability support for programmers, implantable pulse generators, and test systems, providing hands‑on support for both production operations and product development initiatives.
• Drive continuous improvement in product quality and reliability by identifying and implementing process enhancements and product design improvements.
• Own and manage risk management documentation, including reliability, risk and hazard analyses, including Failure Modes and Effects Analyses (FMEAs).
• Provide quality leadership by authoring, reviewing, and approving design and development documentation, protocols, and reports for hardware, software, and firmware.
• Develop, review, and approve test plans and test reports supporting production testing, screening activities, and qualification efforts.
• Lead investigations into returned products, field issues, complaints, and clinical adverse events, performing root cause analysis, health hazard evaluations, and supporting CAPA activities with thorough documentation.
• Generate, review, and approve Nonconforming Material Reports (NMRs), deviations, product holds, and issue documentation, ensuring effective quality and reliability support for manufacturing operations.
• Generate, review, and approve process evaluations, characterizations, qualifications, and validations, ensuring processes are capable, compliant, and sustainable.
• Plan, coordinate, and oversee supplier and component selection and qualification, ensuring reliable and compliant supply chains.
• Provide statistical analysis and sample size justification to support production and development qualification and validation testing.
• Maintain ownership or provide oversight for assigned CAPA activities, ensuring timely, effective, and well‑documented resolution of quality issues.
• Generate, review, and approve non‑product software documentation, including specifications, validation, and release records supporting field support, manufacturing, and development software applications.
• Develop working knowledge of internal audit practices and support internal audits to ensure compliance with applicable regulations and CVRx standard operating procedures (SOPs).
• Plan, perform, or support Gage Repeatability and Reproducibility (R&R) studies, documenting results to ensure measurement system capability and reliability.
• Support the organization through additional quality‑related responsibilities, as assigned, contributing to team objectives and business needs.

Requirements

• BS Degree in Science or Engineering, or the technical equivalent along with 5 years or more experience in a medical device company.
• Knowledge of FDA QSR and ISO 13485 as well as EU MDR regulatory requirements, guidelines and standards that pertain to medical devices.
• Class II or Class III medical device experience.
• Proven communication, analytical, organizational, and problem solving skills.
• Ability to interface with internal and external customers in all aspects of the product life cycle.
• Ability to apply statistics to solve problems and determine sampling plans.
• Experience with risk and hazard analysis.
• Education or experience in electrical engineering, test engineering, or electronics with software experience.
• Knowledge of additional international regulations, radio equipment regulations, risk management, and cybersecurity standards.
• Active implantables experience.
• Experience with internal and supplier audits.

Benefits

• Normal office conditions.
• Limited work in a controlled area where potentially bio-hazardous devices are decontaminated and then analyzed. Must be willing to undergo the three-vaccination Hepatitis B series, or sign a waiver declining the vaccinations.
• Ability to travel for business as required - up to 25%
• Approved, valid identification for air travel, national and potentially abroad
• Reliable high-speed internet service for times in home-office if hybrid