Tekwissen
Software Development Engineer - Medical Device
Tekwissen, Indianola, Pennsylvania, United States, 15051
Overview:
Tekwissen Group, is a workforce management provider throughout the USA and many other countries in the world. 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 pro ducts.
Job Title: Software Development Engineer - Medical Device
Location: Indianola PA, 15051
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Job Description:
Position Summary:This position will be responsible to perform software development of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.Position Description:
You will be involved in all aspects of the product development lifecycle from requirements to delivery in an agile scrum framework.You will work closely with the product managers, and various cross functional teams to deliver world-class solutions to the customers.You will design and develop high-quality medical devices exhibiting excellent performance that meets product requirements and exceeds customer satisfaction.Major Tasks and Responsibilities of position:
Think big; bring fresh ideas and approaches to design and develop innovative solutions in medical device to meet or exceed customer satisfactionEvaluate different design choices, prototype new technology, and implement technical solutionsUnderstand business impact of design choices, and make technical trade-offs using sound judgementAdopt engineering best practices around software developmentAchieve understanding of product requirement and software requirement to design and develop medical device and improve customer valueAchieve understanding of software risk analysis and its impact on design and implementation of medical deviceDeliver high-quality and scalable architecture designs and codeDesign and develop applications and services using SDLC process for medical device development.Identify opportunities to develop new and better solutions.Participate in code reviews of other software engineers, and design reviewsDevelop any technical documentation needed to accurately represent application design and code.Ensures the development initiatives of the Radiology medical devices complies and adheres to client Standard Operating Procedures that meets regulatory standards and guidance such asFDA 21 CFR 820.30 - Design ControlsFDA Cybersecurity in Medical DevicesIEC 62304 - Software in a Medical DeviceEffectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in the medical device developmentManages own work activities to given objectivesQualifications & Competencies:
Bachelor's degree in computer engineering, Electronics, or Electrical EngineeringMinimum of 5 years of relevant work experience in software engineering including all phases of SDLCGood understanding of software development processes, software architecture and data structure.Minimum of 5 years of experience in programming languages and framework in a medical device development or in a regulated industry: C and C++Minimum of 2 years of experience in Python framework.Minimum of 2 years of experience in Linux Ubuntu and SafeRTOS in a medical device development or in a regulated industry.Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, SonarQube, CI/CD GitHub pipelines.Working knowledge on OS such as Windows.Must be able to manage multiple tasks and manage priorities accordingly.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
Tekwissen Group, is a workforce management provider throughout the USA and many other countries in the world. 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 pro ducts.
Job Title: Software Development Engineer - Medical Device
Location: Indianola PA, 15051
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Job Description:
Position Summary:This position will be responsible to perform software development of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.Position Description:
You will be involved in all aspects of the product development lifecycle from requirements to delivery in an agile scrum framework.You will work closely with the product managers, and various cross functional teams to deliver world-class solutions to the customers.You will design and develop high-quality medical devices exhibiting excellent performance that meets product requirements and exceeds customer satisfaction.Major Tasks and Responsibilities of position:
Think big; bring fresh ideas and approaches to design and develop innovative solutions in medical device to meet or exceed customer satisfactionEvaluate different design choices, prototype new technology, and implement technical solutionsUnderstand business impact of design choices, and make technical trade-offs using sound judgementAdopt engineering best practices around software developmentAchieve understanding of product requirement and software requirement to design and develop medical device and improve customer valueAchieve understanding of software risk analysis and its impact on design and implementation of medical deviceDeliver high-quality and scalable architecture designs and codeDesign and develop applications and services using SDLC process for medical device development.Identify opportunities to develop new and better solutions.Participate in code reviews of other software engineers, and design reviewsDevelop any technical documentation needed to accurately represent application design and code.Ensures the development initiatives of the Radiology medical devices complies and adheres to client Standard Operating Procedures that meets regulatory standards and guidance such asFDA 21 CFR 820.30 - Design ControlsFDA Cybersecurity in Medical DevicesIEC 62304 - Software in a Medical DeviceEffectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in the medical device developmentManages own work activities to given objectivesQualifications & Competencies:
Bachelor's degree in computer engineering, Electronics, or Electrical EngineeringMinimum of 5 years of relevant work experience in software engineering including all phases of SDLCGood understanding of software development processes, software architecture and data structure.Minimum of 5 years of experience in programming languages and framework in a medical device development or in a regulated industry: C and C++Minimum of 2 years of experience in Python framework.Minimum of 2 years of experience in Linux Ubuntu and SafeRTOS in a medical device development or in a regulated industry.Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, SonarQube, CI/CD GitHub pipelines.Working knowledge on OS such as Windows.Must be able to manage multiple tasks and manage priorities accordingly.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.