Functional area: R& D
The Test Designer should be able to analyze the requirements and establish test design techniques. Able to review test cases prepared by other team members, executing the test cases, defect reporting.
Key Areas of Responsibility
▪ Review Master Test (Release) Plan and implement strategy defined.
▪ Review of Requirement and Design documents from test point of view.
▪ Develop, execute and archive objective, reproducible and maintainable test designs and test
cases/scripts (for (sub)system integration, functional and non-functional tests), based on a risk-based
strategy, by using test design methods, techniques and tools.
▪ Analyze, interpret and report test results for both verification and validation purposes.
▪ Provide (pro-actively) feedback to development and system design based upon experiences gained
Job Knowledge, Skills and Experience
Know-how & Skills:
▪ BE in Electrical/Mechanical/Comp Engg Engineering
▪ 2 to 8 years of experience with device SW/HW
▪ ISEB/ISTQB Foundation level knowledge of Test Engineering.
▪ Knowledge on project organization, test processes, strategies & techniques.
▪ Application knowledge of specific test area.
▪ Basic understanding of mechanical, electronic and software development.
▪ Basic level of protocol/networking knowledge.
▪ Understanding of test tools and project management tools.
▪ Has the ability to apply automated test equipment.
▪ Can apply automated testing (write & maintain scripts).
▪ Knows how to participate in reviews from test viewpoint.
▪ Be able to handle ad-hoc changes in priority/planning.
▪ Be able to determine best approach in testing for product/project
▪ Be able to think from customer expectation perspective
▪ Be able to work in different teams simultaneously
▪ Communicative & disciplined team worker.
▪ Affinity with Testing and Improvement
Functional area: R& D
The key purpose of this position is to support the Compliance activity for Mobile surgery systems with all
relevant mandatory international and national standards.
General Key Areas of Responsibility
Work on the project deliverables related to Compliance release evidence
• Identification of relevant clauses from standards for (sub)system
• Secure the implementation and verification of all specified legal requirements.
• Support with respect to technical realization/engineering of compliance of the (sub)system.
• Support the verification (testing, witnessing and reporting and approval) of all specified legal
• Be the intermediary between development and certifying/regulatory agencies (UL/CSA/FDA/KEMA etc).
• Support arrangements for and completion of submission to certifying agencies.
Specific Key Areas of responsibility: Project Manager
- Bachelor degree (preferably in electronics or directly related area.
- Preferably 4 – 7 years of experience
Know-how & Skills:
• Bachelor degree (preferably in electronics/Mechanics or directly related area).
• knowledge of relevant regulations (UL, CSA, IEC, ISO, DHHS, MDD, CE, Pal, etc.).
• knowledge of relevant standards (General Safety, EMC, Radiation Safety, Risk Management,
Environmental, Sustainability, etc.).
• Knows how to participate in Reviews from compliance viewpoint.
• Knows how to write proper submission forms.
• Quality & Regulatory insight.
• Be able to work in teams
• Disciplined team worker.
• Takes personal ownership for own deliverables in terms of content, quality and time.
• Feels committed to agreed team deliverables.
Design Quality and Regulatory Leader
- Around 8-15 Experience in Software Quality Assurance
- Experience as senior software/hardware engineer/module leader/technical leader
- Working experience in quality assurance and Regulatory assurance
- Preferable experience in all areas of Software development life cycle
Diploma/Graduate/Post graduate in Electronic Engineering/Software Engineering with 8-15 of experience
- Practical knowledge of prevailing software/hardware quality standards and models
- Process auditing skills
- Domain competence
- Exposure to applicable regulatory standards such as ISO 13485, FDA 21 CFR 820, IEC 62304 is MANDATORY
- To perform both the functions of a Quality Assurance and Regulatory Assurance role in Medical Device Industry
- To monitor the status and progress of the project independently
- To advice project management on perceived risks in the project
Responsibilities and Key Result Areas: Software Quality engineering activities: Process deployment
- Participation in process definition as per Sector/BU standards, tailoring as per project needs and effective deployment
- Conducting configuration audits along with the QL/Program Quality
- Conducting process audits and compliance checks
- Initiating necessary escalations in case of non-compliance
Active Participation in Development Process:
- Ensuring that the reviews are conducted effectively and also that the review comments are closed and incorporated in the work products
- Ensuring that only the reviewed and tested code is used for integration
- Ensuring release worthiness of all deliverables
- Metrics data collection for the project and analysis, initiating and tracking corrective / preventive actions with the PL
- Defect classification and analysis, initiating and tracking corrective/preventive actions with the PL
- Co-coordinating for project Stage reviews and Audits; ensuring that lessons learnt in project are captured, shared, & acted upon. Interface with global counterparts during software releases, audit and acceptance.