Manager Software Engineering - IVD
Redwood City, CA

Job Description

Overview:

POSITION SUMMARY:

The IVD (In-Vitro Diagnostic) Software Engineering Manager will partner with cross-functional product development teams to lead the research and development of expanding software solutions for new and existing Genomic Health products and services.

This person shall lead a team of talented Engineers, to deliver global, scalable software solutions with a special focus on the development of the IVD (In-Vitro Diagnostic) Product software. This person shall influence and support the development of future products by providing software engineering design and execution expertise to Product Teams, Business Development, and Senior Management

RESPONSIBILITIES / DUTIES:

* Manage and lead the development, oversight, and technical decision making of the IVD Product Software.
* Implement FDA, ISO and Clinical Regulatory solutions, when specified, that are aligned with business needs and meet regulatory standards
* Ensure compliance with software development methodology and process
* Influence and implement engineering standards, frameworks, processes, tools, and disciplines across the Software Engineering organization
* Leverage technology surveillance to enhance existing solutions and drive the development of new ideas and concepts
* Manage and report on progress, obstacles, and technical risks to management and business stakeholders.
* Provide functional and business partners what-if insight to optimize resource use, timelines, and project deliverables
* Influence architecture and solution decisions at all levels of the organization through the use of presentations, technical forums, and review boards
* Collaborate with Cross-functional team to identify, evaluate and manage Project Risk.
* Identify, escalate and solve project issues in a timely and effective manner, partnering with business and technical project leaders
* Promote test-driven development, behavioral driven development, software conventions, design and code reviews, and another software engineering best practices as a vehicle for delivering high-quality solutions.
* Ability to manage team performance and effectiveness, across onshore and offshore employees and contractors
* Foster a collaborative team environment to bring forth the best ideas and solutions but at the same time know when to make a decision
* Team development including hiring, coaching, goal setting and sharing of best practices
* Provide mentorship and guidance to the team to facilitate the career development of individuals on the team
* Manage team morale and foster GHI company culture and values

QUALIFICATIONS:

REQUIRED

* 12 or more years of relevant software engineering, a significant portion of which ideally is within a biomedical / biotechnology company
* Experience in a regulated market space including CLIA, FDA, CE
* Knowledge and experience of clinical software solutions
* Industry experience developing production level software for IVD (In-Vitro Diagnostic) kits or other medical devices in a regulated environment (21 CFR 820 QSR, ISO13485 and IEC 62304)
* 3 - 5 years' leadership and/or management experience in creating and scaling software engineering teams with an understanding and demonstrated the application of SDLC, Agile, source code management, requirements management, and defect tracking systems
* Demonstrated ability to promote team's adherence to processes and industry best practices.
* Demonstrated ability to write and review use cases, software requirements, architecture, design specifications and test plans in a regulated environment.
* Experience working with product and program managers to align on objectives, priorities, trade-offs, and risks
* Demonstrated ability to interact effectively and drive the highly collaborative discussion with cross-functional teams.
* Able to work quickly and effectively under pressure and to efficiently deal with multiple priorities simultaneously
* Ability to fully support R&D group and Quality department by building quality into all aspects of work and by maintaining compliance to all standard operating procedures
* Experience managing, developing and shipping large-scale projects
* Excellent verbal and written communication skills
* Strong analytical and problem-solving skills
* Demonstrated leadership abilities and enthusiasm to hire, mentor, and inspire a group of technical professionals
* Maintain and improve the GHI company culture by sourcing and hiring only the most qualified individuals with an eye towards diversity & inclusion

DESIRED

* Experience with development and commercialization of products outside the United States
* Strong background in API development, micro-service/service-oriented design, object-oriented programming (OOP), software design and architecture using best practices
* Experience with Software development. Demonstrated proficiency in Java and/or Windows software development including Java/C#/.NET
* Experience working with LUA scripting language
* Background in API development, micro-service design, web application development

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

You will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.

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This person shall influence and support the development of future products by providing software engineering design and execution expertise to Product Teams, Business Development, and Senior Management.