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Sr. IVD Software Engineer

Apply Share Job ID 1001 Category Information Technology Job Location Redwood City, California Posted Date 12/11/2018

Overview:

POSITION SUMMARY:

Genomic Health is looking for a motivated, experienced, and creative Senior Software Engineer to join its fast-growing in-vitro diagnostics (IVD) team and play a key role developing our IVD devices. The successful candidate will work closely and collaboratively with Genomic Health's scientists and engineers and shall use his/her expertise as a lead in the design and development of IVD software. She/he will play a key role in the software development lifecycle by applying his/her expertise in design, development, regulatory, compliance, and process optimization.


RESPONSIBILITIES / DUTIES:

· Perform all phases of the software development lifecycle (SDLC) for IVD devices that are intended for FDA/ISO submission.
· Lead and engage hands-on in development, writing and reviewing software requirements, design specifications and test plans for overall software infrastructure for Genomic Health IVD devices
· Responsible for ensuring compliance to software development methodology and process which must meet regulatory requirements
· Demonstrate regulatory best practices and disciplines across the Product Software engineering organization
· Mentor and guide the group as a subject matter expert when it comes to navigating the regulatory software documentation space
· Closely work with hardware vendors, software and UX design teams to capture and implement design needs.
· Employ test driven development, behavioral driven development, software conventions, design and code reviews, and other software engineering best practices as a vehicle for delivering high quality solutions.
· Surveil and recommend technology to enhance existing software platforms/frameworks and drive the development of new ideas and concepts
· Effectively communicate and influence architecture and solution decisions at all levels of the organization using presentations, technical forums, and review boards
· Implement FDA, ISO and Clinical Regulatory solutions, when specified, that are aligned with business needs and meet regulatory standards
· Foster a collaborative team environment to bring forth the best ideas and solutions


QUALIFICATIONS:

REQUIRED
· BS or MS in computer engineering, computer science, or related field.
· 12+ years of software engineering experience utilizing software engineering best practices (SDLC)
· 5+ years of industry experience developing production level software for in-vitro diagnostic kits or other medical devices in a regulated environment (21 CFR 820 QSR, ISO13485 and IEC 62304)
· Strong background in software engineering fundamentals and concepts, service oriented design, object oriented design/programming (OOD/OOP)
· Ability to adapt and manage ambiguity and deal with multiple priorities simultaneously
· Experience working on cross-functional project teams including biologists, chemists, and engineers
· Experience with risk management activities (ISO 14791)
· An independent thinker and problem-solver, who is an enthusiastic and collaborative professional
· Excellent written and oral communication skills and proven ability to work well in a team environment
· Ability to assess design issues and propose/implement appropriate application architecture and testing methodology, including unit and integration tests.
· Ability to mentor team members.
· Demonstrated ability to work cross-functionally, cross-site, and cross-culturally.
· Excellent team player, self-motivated and self-directed.
· Demonstrated proficiency in Windows software development including C#/.NET
· Passionate about impacting the lives of patients through transforming treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics and services

DESIRED
· 2+ years software engineering leadership experience
· Background in API development, micro-service design, web application development
· Experience with development, launch, and support of products outside the United States
· System/deployment administration experience in a 24X7, high availability production environment
· Cloud, Integration and Scientific platform experience (AWS, Azure, Google)

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

· Travel Requirements: 5-10% Travel
· Use of computer, and or telephone for long periods of time may be necessary
· Considerable periods of time may be spent concentrating and or analyzing data
· Considerable periods of time may be spent communicating verbally and in various written forms including presentation material and email with other people
· At times, stress may be experienced.
· Standing or sitting for long periods of time may be necessary


Join the Genomic Health Team, and have the rare opportunity to make a difference in the lives of patients with cancer, while developing your career potential. We value our employees and consider them an integral part of our company's growth and success. We maintain competitive total rewards programs designed to satisfy our employees' work life and personal life needs. To learn more about careers at Genomic Health visit:http://www.genomichealth.com/join_our_team

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Genomic Health is looking for a motivated, experienced, and creative Senior Software Engineer to join its fast-growing in-vitro diagnostics (IVD) team and play a key role developing our IVD devices. The successful candidate will work closely and collaboratively with Genomic Health’s scientists and engineers and shall use his/her expertise as a lead in the design and development of IVD software.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!