Deprecated: mysql_connect(): The mysql extension is deprecated and will be removed in the future: use mysqli or PDO instead in /home/genomichealthjob/genomichealthjobs.com/connect.php on line 3
Senior Process Development Engineer / Project Management - IVD at Genomic Health
Skip Navigation

Search Jobs

Search

Search All Openings
Hero Image

Senior Process Development Engineer / Project Management - IVD

Apply Share Job ID 1145 Category Engineering Job Location Redwood City, California Posted Date 10/16/2018

Overview:

Reporting to the Director of Process Development, this Senior position will provide expertise, vision, and leadership in system integration to the Process Engineering team spanning requirements gathering to validation for in vitro diagnostics (IVD) tests. Efforts will include the design and implementation of Operations processes and infrastructure to support the internal development and scale-up of IVD tests, the integration of externally developed IVD tests, and ongoing improvements of existing commercialized IVD tests.

The successful candidate will participate in and lead cross-functional integration teams with members from many different disciplines and functional areas, including but not limited to, Engineering, Clinical Laboratory Operations, Supply Chain, Manufacturing, Biostatistics, Information Technology, Quality, R&D, and external partners and collaborators.

Integration efforts will encompass the generation and collection of requirements, integration of subsystems, transfer of processes to Operations, and validation of workflows. The Senior Process Development Engineer will provide expertise in engineering design, process development, design transfer and scale-up, and assist in problem-solving with regards to reagents, equipment, software and other systems.

RESPONSIBILITIES / DUTIES:

· Participate in and lead cross-functional teams planning, developing, validating, and implementing robust and scalable solutions and infrastructure for Genomic Health's in vitro diagnostics products in areas from manufacturing and quality control to order-to- cash.
· Incorporate business strategy into project scope, plan, and design that may involve multiple phased releases.
· Collect and document clear and complete business requirements.
· Translate these business requirements to clearly documented, well-vetted requirements for the different hardware and
software systems used as the solution.
· Work with Project Management to build a development schedule and track progress using a robust development
process.
· Advise and present options, recommendations, and plans to senior management on integration projects and associated
issues and risks.
· Provide leadership on best practices for development of processes and products in a regulated environment.
· Apply Robust Design / Design for Six Sigma principles to the development of solutions.
· Serve as a subject matter expert on the business workflows within Genomic Health, providing expertise in this area to
colleagues outside of Engineering.
· When needed, manage engagements with outside partners as necessary to incorporate their laboratory tests into
Genomic Health's business workflows.
· Other duties as assigned.

QUALIFICATIONS:

Required:
· An engineering degree or equivalent and at least 12 years of relevant systems integration experience with complex workflows and products.
· Experience in the design, development, and transfer to production of software components in a highly regulated environment (ISO 13485 or FDA).
· Experience developing and implementing manufacturing and quality control workflows for assay reagents that are integrated with an IVD platform.
· A track record of success in understanding complex end-user applications, collecting and clearly documenting end user
needs, and translating these into clear, concise, and testable requirements.
· Demonstrated experience in verifying and validating complex workflows including assay, equipment, and software components to ensure requirements have been met.
· Superb written and oral communication skills and demonstrated excellence in collaborating with colleagues and
customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization
at many different levels.
· Demonstrated ability to effectively lead and participate in cross-functional project teams.
· Critical thinking skills required to judiciously plan and prioritize project activities for maximum leverage and impact.
· Demonstrated leadership skills required to align colleagues and stakeholders around a vision and a plan to achieve it,
and to execute this plan.
· Strong and consistent commitment to quality.
· Ability to integrate and apply feedback in a professional manner.

Desired:
· Experience with development of business workflows using enterprise software systems for diagnostic applications.
· Experience in the development of IVD tests on automated platforms.
· Experience with multiple analytical assay formats including immunoassays and RT-qPCR.
· Experience in project management.
Apply Share

If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!