Junior Embedded Software V&V Engineer

Indianola, WA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.

Job Title: Junior Embedded Software V&V Engineer

Location: Indianola PA 15051

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Job Description:

Primary Function:

System software verification and validation of radiology device products to meet FDA design controls

POSITION SUMMARY

This position will be responsible to perform 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
Embedded software
Platform software
Operating system software
Development and execution of manual and/or automated 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:
Sub-system testing
Performance and reliability
Safety and interoperability
Review and analysis of product and software requirements
Defect characterization and reporting. Assist in triaging of the defects.
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:

Bachelors degree in engineering preferably Computer Electronics or Biomedical
Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry
Minimum of 1 years of relevant work experience in software test automation
Familiarity with Software Development Lifecycle processes including Waterfall and Agile methodologies
Familiarity with C/C Python languages and test frameworks.
Understands impacts of hardware constraints on software environment.
Familiarity with ST microprocessor FPGA BLDC peripheral device communication and embedded RTOS
Technical writing ability clear and concise writing easily understood by multiple audiences (testers auditors peers etc.)
Have a strong sense of ownership and project outcome.
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
Working knowledge of tools such as Rational Quality Manager GoogleTest JIRA Artifactory Git and 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 tools

TekWisen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies i...