Sr. Software Quality Engineer (Design Quality Engineer for Software) 9/8/2016

Ustech Solutions Carlsbad, CA

Company
Ustech Solutions
Job Classification
Full Time
Company Ref #
29679729
AJE Ref #
576120339
Location
Carlsbad, CA
Job Type
Regular

JOB DESCRIPTION

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JOB TITLE: SR. SOFTWARE QUALITY ENGINEER (DESIGN QUALITY ENGINEER FOR SOFTWARE)

JOB ID: 13801

LOCATION: CARLSBAD CA USA 92008

SUMMARY OF POSITION:
Provide quality software engineering support in design and development of medical device products, specifically ventilation products. Facilitate the application of software design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.

ESSENTIAL FUNCTIONS:
* Strong familiarity with regulatory requirements (e.g. ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820, ISO 14971, ISO 62304).
* Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
* Experience in risk evaluation techniques, e.g. HHE, Product Risk Assessment, SFMEA, DFMEA, PFMEA & fault tree analysis.
* ASQ CQE, CRE, CSQE certification desirable, but not essential.
* Participate in Software development reviews, code reviews and formal software technical reviews
* Review new and modified product designs for quality characteristics, reliability, serviceability, testability and traceable to product requirements.
* Ensure successful transfer of new products to production facility. Review production processes for quality of validation.
* Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
* Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
* Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
* Review Design History Files and Technical Files for conformance to applicable requirements
* Assist, when appropriate with internal and supplier audits.
* Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
* Participate in Software development reviews, Code Reviews and formal software technical reviews.
* Skilled in statistical methods.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.

REQUIREMENTS:
Education: * BS in software engineering.
Experience: * 5-10 years of quality engineering experience or equivalence.

SKILLS/COMPETENCIES:
:* Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
* 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.
Preferred Skills/Qualifications:
* Strong familiarity with regulatory requirements e.g. IEC 62304ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971.
* Experience in risk evaluation techniques, such as FMEA & fault tree analysis.
* ASQ CQE, CRE, CSQE certification desirable, but not essential.

OTHER SKILLS:
* Some travel possible