Senior Quality Engineer

Why work for CVRx?
CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives. 
The Role
The Sr. Quality Engineer is a critical driver of quality and reliability excellence across all CVRx products, spanning new product development, manufacturing, and supplier operations. The position plays a central role in risk management, design validation, supplier and component qualification, and process qualification and validation, ensuring products are safe, effective, and built to perform. The role owns the disposition of nonconforming materials and devices and partners cross‑functionally to investigate and resolve field issues, including CAPAs, complaints, and clinical adverse events, helping protect patients while continuously improving product and process performance.

KEY DUTIES AND 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.

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

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. 

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

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. 

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

• 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