Senior Design Assurance Engineer - Medical Device

CVRx, Inc.•Brooklyn Park, MN

1d•Onsite

About The Position

This position provides quality and reliability support for all CVRx products for new product development, manufacturing and supplier operations. Will provide key inputs to the risk management, design validation, supplier and component qualification, and process qualification/validation processes. Responsible for disposition of nonconforming materials and devices. Assists in addressing field issues, Corrective Action Preventative Action (CAPAs), complaints, and clinical adverse events, as appropriate.

Requirements

BS Degree in Science or Engineering; the technical equivalent of education and experience may be considered
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 - Active implantables experience is preferred
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

Nice To Haves

Education or experience in electrical engineering or electronics with software experience
Knowledge of additional international regulations, radio equipment regulations, risk management, and cybersecurity standards
Experience with internal and external supplier audits

Responsibilities

In-depth understanding and practical application of Design Control and Risk Management Concepts.
Lead risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis (FMEA), and hazard analysis.
Develop, update and maintain Design History File and Desing Input/Output documentation
Lead the quality and reliability support for new hardware, firmware, and software product development projects.
Lead cross functional team to identify and implement effective controls and support product development from concept through commercialization.
Identify and implement strategies for the continuous improvement of the quality functions for which the position is responsible.
Assess compliance with regulations and standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity with responsibilities to generate and maintain regulatory requirements documentation.
Provide input on or generate, review and approve design and development documentation, protocols and reports for product hardware, software, and firmware.
Plan, perform, coordinate, and/or oversee design validation testing and reporting for product hardware, software and firmware and generate protocols and reports as required.
Generate or review and approve Test Plans and associated Test Reports for production and qualification screens and tests.
Lead and support cross functional root-cause investigation and resolution activities.
Generate or review and approve Nonconforming Material Reports (NMRs), Deviations, Product holds and Issues to provide quality and reliability support of manufacturing operations.
Provide input on or generate and review process evaluations, characterizations, qualifications, and validations.
Plan, perform, coordinate, and oversee supplier and component selection and qualification.
Perform, review, and approve equipment selection and qualification activities, as required.
Provide statistical analysis and sample size inputs to production and development qualification/validation testing and data.
Lead investigation of returned products, field issues, complaints, and clinical adverse events with respect to root cause analysis, potential health risks, and CAPA activities, including health hazard analysis and document the results.
Plan, perform, or assist with Gage Repeatability and Reproducibility (R&R) studies of equipment and document results.

Benefits

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 (ESPP) & stock option grants
12 company-paid holidays per year in addition to a generous Flex PTO plan
Generous paid time off for new parents
Company-paid life insurance & disability options
Unlimited growth opportunities in a growing company
Endless training & learning opportunities
Flexible Schedule