Manual V&V Engineer

Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest!

We are looking for a Manual V&V Engineer to join our growing team in Indianola, PA (onsite).

Job Description:

This position will be responsible to perform system & software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.

POSITION DUTIES & RESPONSIBILITIES

• Activities Verification and Validation of software for complex system interactions in medical devices, including:
• Application software Embedded software Platform software Operating system software Development and execution of automated and/or manual software verification protocols, including: Design and development of test scenarios
• Authoring and review of test cases and protocols Performing execution of test cases
• Writing reports
• Responsible for verification of the software platform of the medical device, including: User interface and interactions Performance and reliability Safety and interoperability
• Review and analysis of product and software requirements Defect characterization and reporting. Assist in triaging.
• Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304 Critical analysis of technical situations; identifies problems, and work with the cross-functional team in resolving the problems.
• Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities.
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.

REQUIREMENTS/PREFERENCES Skill & Competency Requirements:

• Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies.
• Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
• This position requires the candidate to work from office.
• Preferences: Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304 Experience with automation framework and automated testing with QT-Squish, Python, Tosca, experience with code reviews.
• Working knowledge on OS such as Windows, Linux flavors Working knowledge of tools such as Rational Quality Manager, Jenkins, JIRA, Git and DOORS Next Gen.
• 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 Outlook, MS Word, MS Excel, MS PowerPoint, MS Project, and other management tool

Benefits
Why QualiTest?

• Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
• Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
• Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
• Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers. Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
• Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
• Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
• Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
• We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
• Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
• A Competitive pay, the salary range for the role is $60,000 - $70,000.
• Intrigued to find more about us?
• Visit our website at https://www.qualitestgroup.com/
• If you like what you have read, send us your resume and let’s start talking!