Job Title: Systems Engineer// PHHJP00010327
Duration: 12 months
Location: Monroeville PA
Outcomes: The successful candidate will:
Successfully help lead cross-functional teams of mechanical, electrical, and software engineers in the development, verification, and validation of new and existing technologies to create innovative and reliable new product designs for the Respiratory Care ventilation product line with an emphasis on Systems Engineering.
Work closely with Marketing in understanding clinical needs, market observation for new products, trends, and competition developments and document product requirements from these needs.
Be responsible for the generation of product requirements documents and contribute to the overall system architecture of new products.
Be responsible for the product Usability File including writing and executing Human Factors and Usability Protocols.
Be responsible for overall product Verification and Validation test requirements including all medical device ISO safety and compliance standards.
Must be able to thrive in a fast paced, team oriented, new product development environment.
The successful candidate will demonstrate:
Leadership - The ability to make things happen by encouraging and channeling the contributions of others, taking a stand and addressing important issues, and acting as a catalyst for change and continual improvement.
Innovation & change - While ensuring quality, look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools. Be flexible to change what is not working well.
Job skills & knowledge – Full knowledge and understanding of the work responsibilities. Successful application of knowledge and skills to produce quality work. Continue to add new knowledge for personal and organizational growth. Proactively share knowledge with others.
Teamwork - A positive team-member, who listens to other opinions, accepts and uses suggestions for improvement and contributes to the overall team effort. Ability to flex assignments in order to meet group objectives and milestones.
Demonstrated experience with creating new concepts, demonstrating feasibility, completing development, documentation, validation, and release of new products.
Demonstrated experience with soliciting and generating Product Requirements.
Minimum of 5 to 10 years of related experience.
Direct experience with European Union Medical Device Regulation, preferred.
Direct experience with ISO Safety Standards for Medical Devices, preferred.
Direct experience with FDA Requirements (including safety and regulatory testing) and their application within a medical product development environment, preferred.
Bachelor of Science in an Engineering Discipline preferred.
APN Software Services Inc.
Direct: 510-402-1061 | Fax: 510-623-5055 | Amit@apninc.com
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