Principal Medical Device Test & Supply Chain Lead (Hybrid)

Cvrx,-Inc.; Brooklyn Park (MN); Hybrid; USD 138,000 - 175,000; Full time

Benefits offered by this job

Health & Dental Insurance

HSA

401(k)

Stock purchase plan

Holidays + PTO

Parental leave

Life insurance

Disability insurance

Growth opportunities

Training & learning

Flexible schedules

Job summary

CVRx, Inc. in Brooklyn Park, MN is seeking a Senior Test Engineer to lead automated test platform development and verification for medical devices. You will define test strategies, develop hardware and software test platforms, and ensure robust production testing using LabVIEW, SQL, and C/C++.

The role demands 15+ years in medical devices, FDA QSR/ISO13485 knowledge, and ability to guide cross-functional teams. Hybrid work, competitive salary, and comprehensive benefits are offered.

Qualifications

• BS Degree in electrical engineering, computer science or software engineering or technical equivalent plus 15 years or more experience in a medical device company
• Experience as an engineer in verification activities, verification systems, and production test systems in the medical device environment
• Development and Test experience in SW and FW using C, C#, Visual Basic, and other programming languages
• Test system software experience using LabVIEW, SQL, and other programming languages
• Knowledge of FDA QSR and ISO 13485 regulatory requirements, guidelines and standards that pertain to medical devices. Knowledge of additional international regulations, radio equipment regulations, risk management and cybersecurity standards is a plus
• Class III implantable medical device experience. Active Implantable device experience is HIGHLY desired and will be prioritized
• 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
• Ability to provide work direction to other technical employees and consultants

Responsibilities

• Identify the strategic direction for automated test platforms to ensure re-usability, scalability, favorable cost, and favorable test times.
• Define and manage projects related to the development of automated test platforms.
• Develop and maintain test platforms (both hardware and software) intended for design verification and production test.
• Develop test specifications, schematics, protocols, and reports for design verification and production test.
• Plan, perform, coordinate, and/or oversee design verification testing and reporting.
• Analyze test results to proactively identify issues and optimize yield for design verification and production test.
• Implement root cause analysis, corrective and preventive actions to resolve product and test issues, including purchased parts.
• Coordinate and/or perform failure analysis and troubleshooting of prototypes, products, and equipment.
• Provide statistical analysis and sample size inputs to production and development of qualification/validation testing and data.
• Plan, perform, or assist with Gage R&R studies of equipment.

Skills

LabVIEW usage

C/C++ programming

SQL analysis

Statistical analysis

Project coordination

Education

BS in electrical engineering / computer science / software engineering

Tools

LabVIEW

SQL

C

C#

Visual Basic

Job description

CVRx, Inc. in Brooklyn Park, MN is seeking a Senior Test Engineer to lead automated test platform development and verification for medical devices. You will define test strategies, develop hardware and software test platforms, and ensure robust production testing using LabVIEW, SQL, and C/C++.

The role demands 15+ years in medical devices, FDA QSR/ISO13485 knowledge, and ability to guide cross-functional teams. Hybrid work, competitive salary, and comprehensive benefits are offered.