Execute software verification and validation test procedures for embedded software in medical devices.
• Read and execute software integration, system, and regression test scripts.
• Document using good documentation practices the executed software test results.
• Participate in system software V&V planning, code reviews, and software defect tracking and resolution.
- Work as a member of a team on projects, using embedded system software life cycle documentation including Software Architecture Documents, Software Requirements, Software Risk Assessments, and other related documents to complete the software verification and validation of new products.
- Accountable to ensure that embedded system software verification and validation activities meet design requirements and the V&V process is carried out in accordance with established procedures.
- Software test scripts include automated test procedures in LabView and C, the software test technician shall be able to run test scripts utilizing these applications.
- Be able to focus on details to identify difference between monitor display and printed information. Visual comparisons can be a series of symbols (e.g. foreign languages).
- Contribute to system level hazard analysis and assist in the generation of test guidelines for software products and/or tools used in software development.
- Work closely with software test team, design control leads and software engineer to ensure compliance with the software development process and KCI standard operating procedures.
- Enter, update, and track software defects and defect status (using defect tracking tools).
- Document the software verification and validation of the product.
- Adhere to standards and help to ensure compliance with FDA and ISO requirements.
- Participate in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conform to, support, and enforce all company policies and procedures.
Position Qualification Requirements:
- High school diploma or GED with 3 years technical experience or technical school certificate.
- Test setup and test execution experience, or related technical experience
- Familiarity with HyperTerminal, or other interface programs.
- Experience with diagnostics tools including oscilloscopes, protocol and logic analyzers.
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
- Must have excellent written and oral communication skills and be a team player.
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
- Associates degree or higher
- Familiarity with C, C++, and LabView.
- Experience with ISO 13485, medical device regulations
- Experience with IEC 62304
The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed. Management may request duties not listed here.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