Principal Systems Test Engineer (Medical Device Manufacturing) - Hybrid

Job Description

Job Description

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.

This role is Hybrid in Brooklyn Park, MN with a required 3-4 days onsite. You must reside in the Greater Minneapolis - Saint Paul, MN area to be considered for this hybrid role. 

CVRx is unable to provide sponsorship (new or transfer) for this work opportunity at this time. 

A day in the life:

As a key member of the operations and development team, this position will provide supply chain and test engineering expertise for all CVRx products for new product development and operations.  Key inputs will be to supplier and purchased product selection and qualification, management of supply chain issues (primarily electrical components), and the development and maintenance of design verification and production testing systems. This position recommends and implements strategic direction for hardware and software test platforms and methodologies.  

Key Duties and Responsibilities:

Test Engineering 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.  This includes maximizing availability, improving test coverage (as needed), and reducing test time.  Test system software uses LabVIEW, SQL, and other programming languages as required. 
• 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. 

General Responsibilities  

• Provide engineering support of production as assigned. 
• Develop and maintain non-product software and firmware; this includes SW/FW items related to field support, manufacturing, and development. SW/FW items use C, C#, Visual Basic, and other programming languages as required. 
• Participate in or lead implementation and support of manufacturing planning/execution software systems.  This includes the implementation of electronic travelers, inventory management, purchased product ordering, etc. 
• Participate in the disposition of nonconforming materials, products, product holds, and deviations. 
• Participate in risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis, hazard analysis, and fault tree analysis. 
• Provide input and approval of design and development documentation. 
• Provide ownership or oversight to specific corrective and preventive action issues, as assigned. 
• Assist in the investigation of returned products, field issues, complaints, and clinical adverse events with respect to root cause analysis, potential health risks, and corrective and preventive action activities. 
• Participate in internal audits for compliance to regulations and CVRx SOPs. 
• Develop and implement strategies for the continuous improvement of the functions for which the position is responsible.  

Perform additional duties as assigned.

REQUIRED EDUCATION, TRAINING & JOB RELATED EXPERIENCE

• 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 

PREFERRED EDUCATION, TRAINING & JOB RELATED EXPERIENCE

• Advanced degree preferred 

• Proven communication, analytical, organizational, and problem-solving skills 

• Excellent interpersonal skills to allow effective participation in project teams 

• Strong organizational and project management skills 

• Experience using six sigma tools 

Working Conditions:

• Normal R&D laboratory, manufacturing floor, and office conditions onsite.  

• Occasional travel (including by air) up to 15% of the time; may include international travel.  

• May be required to be fully vaccinated against the COVID-19 virus and other diseases. 

What we offer

CVRx is proud to offer competitive salaries and benefits plans.

We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun. 

Salary range for U.S locations (USD): 138,000 TO 175,000

The base salary range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.

We also offer a competitive benefits package, details listed below:

• Health & Dental Insurance options with generous Company contributions
• Company contributions to an HSA if enrolled in a high-deductible plan
• 401(k) with company match
• Employee stock purchase plan & stock option grants
• 12 company-paid holidays per year + PTO
• Paid time off for new parents
• Company-paid life insurance & disability
• Unlimited growth opportunities
• Training & learning opportunities
• Flexible Schedules

Compensation and benefits information pertain solely to candidates hired in the United States.

EEO STATEMENT

CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.  

If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!   

If you need assistance or an accommodation due to a disability, you may contact us at View email address on ziprecruiter.com 

This requisition will be open until filled. 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.