Senior Principal / Principal Supply Chain and Test Engineer

CVRx, Inc.•Brooklyn Park, MN

20h•$138,000 - $175,000•Onsite

About The Position

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.

Requirements

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
Experience as an engineer in supply chain engineering activities in a medical device environment
Knowledge of FDA QSR and ISO 13485 regulatory requirements, guidelines and standards that pertain to medical devices.
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

Nice To Haves

Knowledge of additional international regulations, radio equipment regulations, risk management and cybersecurity standards is a plus
Class III implantable medical device experience. Active implantables experience is a plus
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

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.
Identify the strategic direction for sourcing of electronic parts to ensure availability, scalability, and favorable cost.
Proactively identify and implement new sources for electronic parts suppliers, including second sources to minimize risk related to obsolescence and supplier delivery/quality issues.
Participate or lead supplier audits of electronic parts suppliers.
Manage the relationship with electronic assembly contract manufacturers to ensure clear communication of the product forecast, supply chain issues, and other factors as required.
Define and manage projects and vendor relationships related to sourcing of custom electronic parts.
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.