Manufacturing 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.

This is a full-time role and our selected candidate will be expected to work onsite, Monday through Friday, at our Brooklyn Park, MN Headquarters.

A day in the life:

As a Manufacturing Quality Engineer at CVRx, you'll take on a hands-on, impactful role supporting day-to-day production and quality efforts. This role is embedded in our manufacturing environmentworking directly with operators, equipment, and cross-functional teams to ensure our life-changing technology is built to the highest standards. You'll apply technical expertise, problem-solving skills, and attention to detail to continuously improve our processes and systems.

Key Duties and Responsibilities:

• Provide quality and reliability support for manufactured products, including new product development projects.
• Contribute to the identification and rollout of process improvements aimed at enhancing product quality and reliability.
• Lead or participate in the investigation and resolution of Non-Conformances (NMRs) and corrective/preventative actions (CAPAs) related to manufacturing, design and suppliers, including returned product and field complaints
• Lead or support process and equipment evaluations, characterizations, qualifications, and validations.
• Learn and assist with risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis (FMEA), and hazard analysis.
• Act as a technical resource on the production floorinvestigating real-time issues, conducting root-cause analysis, and helping implement quality-focused solutions.
• Assist in supplier and component qualification activities, including hands-on inspection and evaluation of components, sub-assemblies, and manufacturing processes.
• Review and improve incoming inspection and in-process measurements for accuracy or time, as assigned.
• Plan, perform, and/or oversee design validation testing and reporting for new products, designs, or process changes.
• Support product labeling updates and artwork modifications by helping streamline and validate labeling processes.
• Assist in coordinating facility layout changes, tooling qualifications, and capital equipment installations.
• Learn and assist in performing internal and supplier audits for compliance to regulations and CVRx standard operating procedures (SOPs).
• Support external audits (FDA, EU, MDSAP, etc.) for compliance to regulations.
• Learn and gain understanding of regulations and standards in the areas of quality systems, risk management, medical device development, and usability, with responsibilities for assisting with generation and maintenance of regulatory requirements documentation.

Requirements

What we expect from you:

• A Bachelor's degree in Engineering, related technical training or a combination of experience and education will be considered equally
• 0 to 4 years of experience with or an education in manufacturing quality and experience working on the production floor as preferred
• Exceptional verbal and written communication skills.
• Proven experience in contributing to project teams
• Strong interpersonal skills for effective collaboration in project teams
• Excellent organizational and project management abilities
• Familiarity with various computer programs like Microsoft Office 365 and ability to pick up others quickly

What we would like to see:

• Experience within the medical device industry is preferred
• Prior experience with medical device labeling and label printing software is nice to have
• Proficiency in using manufacturing planning software and systems is nice to have
• Knowledge of lean manufacturing principles, demand flow technology, Kanban management, and/or Six Sigma tools is nice to have
• Experience in the manufacturing of implantable leads and implantable pulse generators (IPGs) used in implantable medical device therapies is nice to have

Working Conditions:

• Work is performed in a cleanroom, R&D laboratory, and office environment - this is an onsite position
• Occasional lifting and movement of equipment, with the ability to lift up to 50 lbs

Benefits

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 (or Hourly) range for U.S locations (USD): 75,000- 95,000 per year.

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:

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

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 thingsand 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 hiring@cvrx.com.

This requisition will be open until filled.