Senior Electrical Quality Engineer - CVRx

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.

A day in the life:

This dynamic position ensures the highest quality and reliability for all CVRx products across new product development, manufacturing, and supplier operations. You will play a crucial role in risk management, design validation, and supplier and process qualification. You'll oversee the disposition of nonconforming materials and devices, and tackle field issues, CAPAs, complaints, and clinical adverse events. Join us to make a significant impact on product excellence and patient safety!

• Lead the charge in ensuring top-notch quality and reliability for new hardware, firmware, and software development projects.

• Take the helm in managing and documenting risk management activities, including reliability analysis, risk and hazard assessment, FMEA, and hazard analysis.

• Ensure seamless compliance with quality systems, risk management, and medical device standards, encompassing cybersecurity and usability, while maintaining crucial regulatory documentation.

• Review and green-light design and development documents, protocols, and reports for hardware, software, and firmware.
• Oversee design validation testing and reporting, generating essential protocols and reports.
• Craft or review Test Plans and Reports for production and qualification tests.
• Manage Nonconforming Material Reports, Deviations, and Product holds to bolster manufacturing operations.

• Document process FMEA and offer insights for process evaluations, qualifications, and validations.
• Spearhead supplier and component selection and qualification, along with equipment selection and qualification.
• Execute statistical analysis and provide sample size inputs for qualification/validation testing.
• Tackle CAPA issues, investigate returned products and complaints, and perform root cause analysis and health hazard assessments.
• Produce and review non-product software documentation related to field support, manufacturing, and development applications.
• Assist with internal audits to ensure regulatory compliance.
• Drive continuous improvement strategies for quality functions.
• Conduct Gage R&R studies and meticulously document results.
• Embrace miscellaneous duties as assigned to uphold excellence in quality and reliability.

Requirements

What we expect from you:

• BS Degree in Science or Engineering or technical equivalent plus 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.

What we would like to see:

• Education or experience in electrical engineering or electronics with software exerience.
• Knowledge of additional international regulations, radio equipment regulations, risk management and cybersecurity standards.
• Active implantables experience.
• Ability to participate in internal and supplier audits.

Benefits

What we offer:

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 the opportunity to make a significant impact in an exciting purpose-driven startup environment, while also having fun. We also offer a competitive benefits package, details listed below:

• Company Paid Health & Dental Insurance options.
• 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.
• Rewards & Recognition Programs.
• Employee Referral Program.
• Companywide events.
• Additional employee perks & discounts.

Working Conditions:

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

If you're an independent, self-motivated individual with strong interpersonal skills and a background in medical devices or healthcare, we want to hear from you!