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Senior Software Quality Engineer

San Jose Metro Area, CA

Posted: 10/29/2019 Job Type: Engineering Job Number: JN -102019-25899

Job Description

Senior Software Quality Engineer

Palo Alto, CA


Responsibilities:


Have direct responsibility for execution and corresponding documentation for the follow elements

of the design control process:


Design and Development Planning

Design Input / User Needs Documentation

Verification and Validation Plans, Protocols and Reports

Design Review documents (plans, agendas, minutes, action item follow-up)

System Specifications

Software Requirements Documents

Software Design Documents

Design Transfer Plans / Reports

Risk Management Plans / Reports

Risk Analyses

Traceability Matrices

Software Risk Classification


Provide for ongoing review of design control activities to ensure that all procedures guiding the

processes and outputs of these processes meet applicable regulations and standards.

Propose, review and approve proposed changes to design control and software management

policies and procedures that are a part of the Company s Quality Management System

Provide training to company personnel on Design Assurance related topics.

Participate as a peer with design and development engineers on complex technical topics to

ensure design solutions are compliant with company procedures, adequately mitigate safety

risks, and are likely to be acceptable to regulatory product reviewers.

Develop and implement risk acceptability criteria as a part of the Risk Management Process.

Present complex technical subjects to regulatory reviewers and auditors to ensure approvals and

ongoing compliance of products.

Perform integration and system level verification and validation testing when independence of

results is required.

Provide oversight to the change control and configuration management processes to ensure that changes are appropriately tested and documented prior to implementation and that, as

appropriate, Regulatory Affairs assess changes to determine their regulatory impact prior to

implementation.


Minimum qualifications:


Bachelor s degree in engineering, technology or science related field. Preferred degrees include BSCS, BSCE, BSBE

5+ years of software design assurance or quality engineering experience in the medical device industry including direct experience with software regulated as a medical device in the United States and European

markets.

2+ years experience in software development or software engineering.

Experience participating regulatory audits and presenting complex technical subjects to regulators as a

part of pre-market reviews.

Significant experience in developing software engineering documents as components of a Design History File including; Design and Development Plans, Design Inputs and Outputs, Verification and Validation protocols and reports, Design Transfer Plans, Design Review Minutes, Risk Management Plans, Risk Analyses.

Ability to link technical and systems strategies into the overall business strategy for the company.

Excellent written and verbal communication skills.


Preferred qualifications:


Master s degree in engineering, technology, or science related field.


Skill/Experience/Education

Mandatory


5+ years of software design assurance or quality engineering experience in the medical device industry including direct experience with software regulated as a medical device in the United States and European markets.

2+ years experience in software development or software engineering.

Experience participating regulatory audits and presenting complex technical subjects to regulators as a part of pre-market reviews.

Significant experience in developing software engineering documents as components of a Design History File including; Design and Development Plans, Design Inputs and Outputs, Verification and Validation protocols and reports, Design Transfer Plans, Design Review Minutes, Risk Management Plans, Risk Analyses.

Ability to link technical and systems strategies into the overall business strategy for the company.

Excellent written and verbal communication skills.


Desired

Preferred qualifications:


Master s degree in engineering, technology, or science related field.

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