Senior Embedded Software Engineer
Posted on: September 17, 2023
This position is responsible for the design, development and
manufacturability of software related
product(s)/system(s). 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
General Description and Duties:
--- Software Engineering: Establishes functional requirements,
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
Recommends and/or selects vendor and material choices for 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
software unit/integration testing, white box testing, and code
--- Product Enhancements: Provides feedback to the development
staff on client specific
enhancements as well as new applications for base product. Acts
research design and develop new products and current product
--- 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
--- 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
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
--- 3 years programming and test on complex software systems.
Keywords: Lrandassociates, Irvine , Senior Embedded Software Engineer, IT / Software / Systems , Irvine, California
Didn't find what you're looking for? Search again!