ENVISN INCORPORATED
Software Development Engineer Medical Device
ENVISN INCORPORATED, Indianola, Pennsylvania, United States, 15051
Job Title: Software Development Engineer - Medical Device
Location: Indianola, PA (Onsite role) Duration: Long term contract
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 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 satisfaction • Evaluate different design choices, prototype new technology, and implement technical solutions • Understand business impact of design choices, and make technical trade-offs using sound judgement • Adopt engineering best practices around software development • Achieve understanding of product requirement and software requirement to design and develop medical device and improve customer value • Achieve understanding of software risk analysis and its impact on design and implementation of medical device • Deliver high-quality and scalable architecture designs and code • Design 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 reviews • Develop any technical documentation needed to accurately represent application design and code. • Ensures the development initiatives of Radiology medical devices complies and adheres to Standard Operating Procedures that meets regulatory standards and guidance such as o FDA 21 CFR 820.30 – Design Controls o FDA Cybersecurity in Medical Devices o IEC 62304 – Software in a Medical Device • Effectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in the medical device development • Manages own work activities to given objectives
Qualifications & Competencies: Bachelor’s degree in computer engineering, Electronics, or Electrical Engineering • Minimum of 5 years of relevant work experience in software engineering including all phases of SDLC • Good 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
Location: Indianola, PA (Onsite role) Duration: Long term contract
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 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 satisfaction • Evaluate different design choices, prototype new technology, and implement technical solutions • Understand business impact of design choices, and make technical trade-offs using sound judgement • Adopt engineering best practices around software development • Achieve understanding of product requirement and software requirement to design and develop medical device and improve customer value • Achieve understanding of software risk analysis and its impact on design and implementation of medical device • Deliver high-quality and scalable architecture designs and code • Design 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 reviews • Develop any technical documentation needed to accurately represent application design and code. • Ensures the development initiatives of Radiology medical devices complies and adheres to Standard Operating Procedures that meets regulatory standards and guidance such as o FDA 21 CFR 820.30 – Design Controls o FDA Cybersecurity in Medical Devices o IEC 62304 – Software in a Medical Device • Effectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in the medical device development • Manages own work activities to given objectives
Qualifications & Competencies: Bachelor’s degree in computer engineering, Electronics, or Electrical Engineering • Minimum of 5 years of relevant work experience in software engineering including all phases of SDLC • Good 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