Job Title - LabView Developer
Job Location - Carlsbad CA
Length - Contract (6 Months+)
JOB DESCRIPTION SECTION
Provide quality software engineering support in design and development of medical device products. Facilitate the application of software design controls in product development and sustaining changes.
Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
Review new and modified product designs for quality characteristics, testability and traceable to product requirements.
Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
Review Design History Files and Technical Files for conformance to applicable requirements
Assist, when appropriate with internal and supplier audits.
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Contribute to software life cycle process improvements
Responsible for validating internal Quality System Applications/Tools.
Create all required documents for Intended Use Validation of Quality System Tools.
Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
Understanding of Object-Oriented Programming
Proficient in LabVIEW and C++.
Experience with analyzing data from SQL databases and writing SQL queries
Understand the processes and intent of all aspects of the QMS related to Design Controls
In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 Medical Device Directive and EU Medical Device Regulations
Skilled in test plan development and root cause/failure analysis.
Good verbal (including presentation) and written communication skills, especially technical report writing.
Ability to effectively work on project teams.
Department Specific/Non-Essential Functions:
Other duties as assigned with or without accommodation.
Minimum 3 years of software quality engineering experience or equivalence.
Preferred Skill Set:
Familiarity with regulatory requirements e.g. IEC 62304, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971.
Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment.
ASQ CQE, CSQE certification desirable, but not essential.
National Instruments TestStand, LabVIEW knowledge and experience highly desirable
Experience with Software Reliability
BS in Software related disciple or equivalent work experience.