Principal Software Quality Engineer ( 1st & 2nd Shift)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Responsibilities may include the following and other duties may be assigned:
- Develop modify apply and maintain standards for software systems quality operating methods processes and procedures.
- Conduct evaluation of software systems activities including requirements design development documentation integration test verification and validation.
- Define and implement appropriate measures to ensure product quality.
- Review software systems design change specifications and project plans against contractual and regulatory requirements.
- Ensure compliance with applicable specifications tools techniques and methodologies.
- Provide or direct verification and validation of software system requirements traceability and testability.
- Lead and oversee projects from design to implementation ensuring compliance with policies and industry regulations.
- Represent the organization as primary contact for projects/initiatives communicating with internal and external stakeholders.
- Provide mentorship coaching and training to other professionals within the team.
Experience Requirements:
- Minimum7 yearsof relevant experience in quality engineering or programming (excluding laboratory micro/chemistry experience).
- Advanced degree accepted with minimum5 yearsof relevant experience.
- Automation / Controls / Programming hands-on experience
- CAPA investigations root cause analysis and technical writing
- Computer software validations and GAMP knowledge hands-on experience
- (Additional) Strong knowledge in medical devices regulations
- Experience with risk management documentation (PFMEAs)
- Experience designing validation strategies (e.g. requirements flow down from design to manufacturing)
- Perform and/or review process validation and equipment documents: URS FAT IQ OQ PQ TMV (not cleaning or laboratory processes)
- Knowledge of medical device regulations and GAMP standards
Education Requirement:
Bachelors degree in Engineering (Mechanical Electrical or Computer/Software preferred).
Technical Skills (Must Have)
- Investigation and root cause analysis skills
- Technical writing knowledge
- Strong organizational and communication skills
- Process validation and computer software validation knowledge
- Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports
- Experience in medical devices manufacturing
- Interpersonal skills to support product disposition investigations (PFMEA atypical events)
- Automated source code management
- Computer software programming (including embedded software programming)
- Development of control plans and PFMEA
Additional Technical Areas (Hands-On/Knowledge Required)
- Programmable Logic Controllers (PLC):Rx Logix configuration & troubleshooting
- Vision Systems
- Instrumentation:overview and application
- Control Systems
- Data Structure & Sources
- Data Analysis Tools:SQL Python R
- Data Management
- Databases:data extraction transformation loading database creation/maintenance query overview (SQL/Non-SQL)
- Programming:Assembly (C) Object-Oriented Programming (Python Java) error handling abstract data types
- GUI/HMI Design:FactoryTalk RSView
- Communication Networks
- Operating Systems
- FDA CSA Guidance:knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance 2022)
Nice to Have
- Additional investigation and root cause analysis expertise
- Full time contract
- 100% on-site job in Medtronic- Juncos PR
- First contract until August 2026basedto performance and budget availability.
- Willing to work 1st or 2nd shift
Required Experience:
Staff IC
Key Skills
- Continuous Integration
- Docker
- Jenkins
- Python
- System Design
- Agile
- C/C++
- Go
- Systems Engineering
- Software Development
- Java
- Distributed Systems
