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Software Engineer - Medical Device - Direct Hire

Goleta, CA, United States

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is seeking a Software Engineer responsible for software development, maintenance, unit verification, integration, and documentation, and adhering to the established Quality Standards. This person will be capable of implementing significant portions of software modules based upon well-defined requirements.

Primary Responsibilities

Work as a member of an agile development team to develop embedded and/or application level software for medical devices.

Design, implement, and test software. Software development (includes new projects and maintenance projects) to be done per the established Quality System.

Create and maintain associated documentation.

Interacts well within a group, requiring some direction from manager and senior team members.

Able to identify and act upon issues and problems that arise.

Assist with the adoption of best practices.

Qualifications

2+ years of experience in software development.

Medical product development experience desired.

Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001).

Experience with design documentation for software.

Knowledge of the Linux platform and tools (gcc, gdb, make, shell scripting, etc.) is required. Understands cross platform issues and is able to learn new platforms quickly.

Experience working with RTOS, cross-compilers, and other technologies in embedded applications is desired.

Familiarity with Internet technologies, communication protocols, networking, network security, and related techniques is desired.

Familiarity with current software development best practices, object-oriented design, SOLID, event-driven architecture, multimedia processing, interface design, localization, portability, extensibility, and testability.

Knowledge of C/C++ and associated debugging techniques.

Good communication skills.

Good project planning and estimating skills; able to keep project moving through daily obstacles, and asks for additional assistance when appropriate.

Self-motivated; works within the team with some supervision from senior engineers and/or manager.

Enthusiastic about the company and about developing its high quality medical products.

Good software design skills.

Writes clear, maintainable, well-documented, portable code.

Recognizes problems and helps the group adapt to changing conditions.Knowledge of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.

Education & Certifications

BS/MS in Computer Science, Electrical Computer Engineering or related field.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.

Operate other office productivity machinery, such as a calculator, scanner, or printer.

Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Base salary/hourly rate (W2): USD 80000 – 100000

Note: This is a direct hire position with our client.

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