Principle Responsibilities: (essential job duties and responsibilities)
- Develop V&V software test project plans including regression planning and testing of software during the development process
- Effectively manage test project schedules by communicating project work load, executing these planned activities, and coordinating with the larger project team.
- Plans and executes team meetings including but not limited to Test Approach, Test Readiness, and Pre-Release Review. Participates in project team meetings.
- Works closely with Design Lead, Software Lead, Design Control Lead, and project managers to ensure compliance to Acelity/ KCI software development procedures and software standards.
- Contributes to system level hazard analysis and software risk assessments.
- Coordinates project software test workflow prioritization, forecasts their resource requirements, and communicates changes.
- Generates test guidelines for testing software during development, designs and builds tools/ fixtures for embedded software during the development phase.
- Develops and implements automated test procedures to streamline testing processes. Places a strong emphasis on continuous improvement and cost effective innovation through new and improved technologies and innovative processes.
- Coordinates test activities with the project team. Generates software test documentation compliant to Acelity procedures.
Software Testing Process:
- Software project teams use embedded system software life cycle processes; including Software Architecture Documents, Software Requirements, Software Risk Assessment, Requirements Traceability, Anomaly Tracking, Requirements Verification and other related documents to complete the embedded system software verification.
- Apply software standards such as TR 80002-1, AAMI TIR32:2004, and IEEE Std 828TM to ensure that software testing is compliant, risk based and appropriately documented.
- The Software Engineer II develops and executes software verification plans, test procedures (automated and manual), and generates reports. Documents shall be compliant to internal processes and regulatory requirements.
- Enter, update, and track software anomalies, and software change requests. Document verification of correction to anomalies and close anomalies as applicable.
- Provide technical assistance to the software team, Quality and Engineering groups throughout the early production builds and launch.
- Develops nimble software to automate embedded software system testing. Testing needs will change with each embedded software release and the automating testing will need to be modular.
- Uses current industry standards (e.g. ISO, IEEE, CMMI) when developing test software.
- Works with Lab Manager to create a safe work environment within the V&V lab and is complaint to safety processes.
- Identifies hazardous workplace conditions and works with team to determine solutions.
- Maintains training on safe work procedure training courses.
- Supports the training of new software technicians to Acelity/ KCI software verification processes.
- Ensure technicians are trained to new test methods, including use of tools/ fixtures.
- Training production as part of project launch may also be required.
- Conform to and support Company policies and procedures.
- Perform other duties as assigned.
Skills and Experiences:
- Experience in regulated laboratory environments, FDA or ISO registered work experience
- Strong technical problem solving skills.
- Good organizational and time management skills.
- An approachable manner and good communication skills.
- Good technical writing skills with the ability to produce clear work instructions.
- Ability to work effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
- Excellent problem-solving skills with effective decision making skills
- Flexibility with working hours.
- An awareness of health and safety issuesMoreInformationDesc
- Continuous Learning
- Task Variety
- Managing Work
- Building Partnerships
- Coaching Others
- BS in Computer Science, Computer Programming, or Electrical Engineering.
- Experience in Software Quality Engineering or Software Test Methodologies
- Experience in regulated industry, medical devices preferred
- Working knowledge of design, development, and debugging of embedded systems
- Familiarity control software, such as LabView and C++.
- Masters degree in Computer Science, Computer Programming, or Electrical Engineering.
- Working knowledge of PEMAC, NuGenesis, and/or Agile.
- Broad base of experience in the development and testing of electronic, electro-mechanical, mechanical, and software systems in the medical device industry.
- Cyber security knowledge and experience.
Education: Bachelors degree in Computer Science, Computer Programming, or Electrical Engineering
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor