This position is responsible for the design, development and manufacturability of software related
This position complies with Quality System by engaging in appropriate levels of GMP/ISO test
methodologies, adherence to Quality System Design Controls, and applies proper documentation
skills.General Description and Duties:
• Software Engineering: Establishes functional requirements, deliverables, timelines,
budgets and develops corporate status reports of projects/products. Works with project
team to develop detail specifications, construction of prototypes, pre-clinical trials for new
products or current product enhancements. Prepares and delivers status reports. Develops,
sets up, and runs product testing and protocols in accordance with project plans.
Recommends and/or selects vendor and material choices for product. Ensures product
documentation is in accordance with Quality System requirements. Assists in the reaction
and maintenance of software specifications. Participates in software risk hazard analyses.
Complies with software validation requirements. Participates in appropriate test plans and
reports for software verification and validation work as necessary. Provides for evolution of
requirements, stress test coverage and maintain verification trace matrices. Performs
software unit/integration testing, white box testing, and code inspections.
• Product Enhancements: Provides feedback to the development staff on client specific
enhancements as well as new applications for base product. Acts independently to
research design and develop new products and current product enhancements.
• Manufacturability: Designs new software or software enhancements in a cost effective
and timely manner and with an understanding of how the product will be manufactured and
used. Contributes to or leads the process of transferring product from development to
• Sales: Participates in customer meetings, trade shows, etc. upon request. Keeps abreast of
competition and trends in the field and market.
• Regulatory Acceptance: Provides engineering testing and documentation that is in
accordance with regulatory requirements for approvals of products by the U.S. and foreign
• Intellectual Property: Works with senior staff and/or attorneys in writing and researching
patents. Participates in and contributes to brainstorming sessions to generate new
• Experience using oscilloscopes, logic analyzers, and other related tools.
• Experience working with domestic and international regulatory agencies. Knowledge of ISO
13485 and FDA QSR is desired.
• Strong project management and communication skills.
• Detail oriented and well organized.
• Bachelor’s degree in Computer Science, Computer Engineering, or other appropriate
engineering science field.
• 2 years working on Class III medical device embedded software development, or software
development or other highly regulated industry.
• For Senior Embedded Software Engineer, 5 years working on Class III medical device
embedded software development or other highly regulated industry.
• 3 years programming and test on complex software systems.