Provide software quality engineering support in design and development of medical device products. Facilitate the application of software design controls in product development and sustaining changes.
Essential Functions:
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 Non-Product Systems Software
Create all required documents for Non-Product Systems Software
Provide support on Non-Product Systems Software for various groups within the business
Skills/Competencies:
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
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 and the Medical Device Directive.
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.
Experience:
3-5 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 is desireable
Education:
BS in Software related disciple or equivalent work experience.
Physical Requirements:
This position functions in an environment that requires the ability to interface with standard office equipment such as computers, printers, copiers, fax, telephones, etc. Position will spend periods of time sitting, standing, walking, etc., as part of the normal conduct of daily business affairs.
Lifting up to 25 lbs
location: Carlsbad, California
job type: Contract
salary: $1 - 45 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
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 Non-Product Systems Software
Create all required documents for Non-Product Systems Software
Provide support on Non-Product Systems Software for various groups within the business
qualifications:
Experience level:
Minimum 3 years of experience
Education: Bachelors
skills:
Quality
SQL
Quality
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
