CVRx | Barostim

Senior Quality Engineer

CVRx | Barostim

full-time

Posted on:

Location Type: Hybrid

Location: Brooklyn Park • Minnesota • United States

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Job Level

Senior

Tech Stack

Cyber Security

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
risk managementFailure Modes and Effects Analyses (FMEAs)statistical analysisGage Repeatability and Reproducibility (R&R)test planstest reportsCAPA activitiesNonconforming Material Reports (NMRs)process evaluationsvalidation testing
Soft Skills
communicationanalytical skillsorganizational skillsproblem solvingleadershipinterpersonal skills