Senior Manager – Quality Assurance
Sullivan & Cromwell LLP
Assembly
Electrical Engineer - Manufacturing Operations
CVRx | Barostim
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $85,000 - $90,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Support production staff when technical issues arise, perform root-cause analysis on said issues, and implement quality solutions in a timely manner.
- Research, build business case, and implement capital expenditures to improve operational efficiencies in a manufacturing environment.
- Develop and recommend new processes and technologies to improve product quality and cost-effectiveness.
- Follow established manufacturing techniques and operating equipment specifications, identifying process improvements and resolution to issues where possible.
- Participate in providing technical direction, training, and certification for operators performing detailed process steps to ensure that production assemblers, testers, inspectors, and support staff have necessary skills, appropriate documentation, tooling, and process control capability.
- Participate in the qualification and development of suppliers for components, sub-assemblies, and processes.
- Implement design and development activities related to operations assessment, process development, and product validation.
- Provide technical direction, training, and certification for operators performing detailed process steps to ensure that production assemblers, testers, inspectors, and support staff have necessary skills, appropriate documentation, tooling, and process control capability.
- Support non-conforming material reports (NMR) and corrective and preventative actions (CAPA) processes.
- Support day-to-day operations relating to manufacturing, supply chain and facilities as necessary.
- Perform miscellaneous duties as assigned by manager.
- Develop and build test environments and test cases for manufacturing mechanical and electrical systems.
- Develop test plans and strategies based on regulatory requirements, industry standards, and product specifications.
- Design and execute test protocols to evaluate the performance, functionality, and safety of medical devices.
- Support the creation and maintenance of software programs and algorithms to support automating test procedures.
- Design, assemble and operate custom test fixtures and equipment.
- Participate in establishing test procedures and coordinating testing of products under development.
- Document technical issues and solutions and suggest fixes and improvements.
- Perform failure analysis and troubleshooting as required.
- Analyze test results, detect issues and track root causes.
Requirements
- Bachelor’s degree in Electrical Engineering, Computer Science, Physics, or relevant field.
- 3 – 7 years’ of work experience in a manufacturing environment or similar.
- Working knowledge of standard electrical tests and test equipment such as voltmeters, power supplies, oscilloscopes, etc.
- Ability to perform basic statistical analysis of test data using statistical tools, such as Minitab.
- Working knowledge of NI LabVIEW software.
- Excellent problem-solving, teamwork, communication, analytical, and organizational skills.
- Self-motivated and self-driven.
- Basic PC skills including Windows, Excel and Word.
- Proficiency with technical writing.
- Experience within the medical device manufacturing industry.
- Work is performed in a normal R&D laboratory, controlled assembly area, and clean room environments.
- Capability of lifting light loads.
- Ability to travel for business as required.
- May be required to be fully vaccinated against the COVID-19 virus and other diseases.
