Software Quality Engineer (Mid)-Project Engineering-E&T-PH-US
Company: PDS Tech, Inc.
Location: Indianola
Posted on: March 19, 2023
Job Description:
PDS Tech, Inc. is seeking Software Quality Engineer
(Mid)-Project Engineering-E&T-PH-USPOSITION/TITLE: Software
Quality EngineerDEPARTMENT/TEAM DESCRIPTION:
- Radiology Software Assurance & Operations Team Primary
Function:
- Software Quality Management of Radiology device products to
meet FDA design controls and other regulatory bodies
- Software Quality Management of GxP relevant computer
systemsPOSITION SUMMARY:
- This position will be responsible to perform software quality
management activities of medical devices (Class-2) to deliver a
high-quality product that meets or exceeds customer expectations
and meets FDA design controls and other regulatory bodies.POSITION
DUTIES & RESPONSIBILITIES:
- Activities
- Software Quality Management of Software in Medical Device
(SiMD) of Class-2 and Class-1 medical devices, including
Application software, Embedded software, Platform software,
Operating system software
- -Software Quality Management of Software as a Medical Device
(SaMD) of Class-2 and Class-1 medical devices, including
Application software, AI/ML software, Platform software including
IaaS and PaaS, Cloud based software
- Responsible for ensuring development initiatives of our company
-Radiology medical devices complies and adheres to regulatory
standards and guidance such as FDA Design Controls CFR 820.30, IEC
62304 - Software in a Medical Device, IEC 82304 - Software as a
Medical Device, IEC 14971 - Risk Management, ISO 13485 - Quality
Management Systems, 2017/745 - European Union Medical Device
Regulation (EU MDR) and various FDA guidance Pre-market submission
guidelines, General Principles of Software Validation, Off The
Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device:
Clinical Evaluation
- Conducts evaluation of software engineering activities of
medical device development including requirements, software risk
analysis, design, development, documentation, integration,
verification, validation and release to deliver medical devices
that are safe, secure and effective * Reviews all the deliverables
of medical device software lifecycle and provide clear, concise,
and timely feedback to stakeholders * Responsible for ensuring
computer system validation initiatives in our company -Radiology
organization complies and adheres to standards and guidance such as
General Principles of Software Validation, Computer Software
Assurance for Production and Quality System Software, FDA CFR Part
11 Compliance
- Provides guidance to cross functional teams to ensure software
quality objectives are met for medical device software
development
- Engaging in continuous improvement initiatives to establish
Center of Excellence (CoE) in Software Assurance function such as
Software Problem Resolution meetings and documentation, CAPA
actions, Process and template updates and Audit support
REQUIREMENTS/PREFERENCES Skill & Competency Requirements:
- Bachelors degree in Computer Engineering, Electronics, or
Electrical Engineering
- Minimum of 7 years of relevant work experience in software
engineering or quality engineering in medical device
development
- Minimum of 2 years of relevant work experience in software
quality management of Class 2 or Class 3 medical devices including
Software in Medical Device (SiMD) or Software as Medical Device
(SaMD)
- Minimum of 2 years or more of experience in interpreting
industry standards for medical device development and updating
processes and procedures
- Quality Management System - ISO 13485 o SiMD - IEC 62304 o SaMD
- IEC 82304 o FDA 21 CFR 820.30 o 2017/745 - European Union Medical
Device Regulation (EU MDR)
- Minimum of 2 years or more of experience in applying industry
standards for medical device development as follows o General
Principles of Software Validation o FDA CFR Part 11 Compliance
- Must be able to handle multiple tasks/projects and manage
priorities accordingly.
- Technical writing ability - clear and concise writing easily
understood by multiple audiences (auditors, peers, etc.)
- Ability to work in-officePreferences:
- Familiarity with AI/ML based medical device software quality
management
- 2 or more years of relevant work experience in various phases
of software development lifecycle including requirements,
architecture, design, development, testing, release, deployment,
post-launch support activities
- 2 or more years of programming experience in any of the
following languages C, C#, Java, React JS, Angular
- Working knowledge of tools including JIRA, AWS, GitHub,
Rational Quality Manager, DOORS Next Gen
- Working knowledge on OS such as Windows, Linux flavors
- Demonstrated ability working in a matrix/hybrid organization
structure
- Ability to troubleshoot and make quick knowledge and
experience-guided decisions
- Excellent written and oral communication
- Excellent people skills, ability to partner well, good team
camaraderie
- Proficient with Microsoft Office tools especially MS Word, MS
Excel, MS PowerPoint, MS Project, and other management toolsPDS
Tech, Inc. is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, sex, sexual orientation, gender identity, religion,
national origin, disability, veteran status, age, marital status,
pregnancy, genetic information, or other legally protected status.
Founded in 1977, PDS Tech, Inc. is one of the nation's premier
specialty staffing firms with 31 offices nationwide. We offer a
full range of benefits including:
- Health insurance
- Paid holidays
- Weekly payroll
- Immediate 401(k) eligibility
- Completion Bonuses
- Training
- Please note availability of benefits may vary by position PDS
specializes in Engineering and IT arenas including Aerospace,
Defense, Electronics, Telecommunications, Automotive, and Energy
just to name a few. Our reputation, track record, and years of
continuous growth reflect the commitment to quality that our
employees and clients experience first-hand. To find out more about
PDS, please visit $$$ PDS pays for referrals! $$$
Keywords: PDS Tech, Inc., Pittsburgh , Software Quality Engineer (Mid)-Project Engineering-E&T-PH-US, IT / Software / Systems , Indianola, Pennsylvania
Didn't find what you're looking for? Search again!
Loading more jobs...