The Senior Technical Software Project Manager will be directly responsible for ensuring that various software components of Roche Sequencing end-to-end solution stack are developed within the proper process and technical expectations to meet overall solution readiness goals. This includes working with internal and outsourced development partners for the various system solutions to ensure that the software meets technical and schedule expectations, along with helping facilitate trade-off decision making across solution-level software projects.
Responsible for delivery of the solution in time, budget, scope, and quality.
Pull together an end-to-end solution software development technical project plan/schedule and determine where and what each component has to deliver to meet the end-to-end expectation
Monitor the project plan and follow up on all teams with action items, delivery schedule, etc. to make sure that project commitments are being held.
Create and oversee program level updates/feedback with a core team of stakeholders, such as the lifecycle project leads and within Software and Bioinformatics organization.
Work with the project team members to ensure that software requirements and corresponding software interface specifications at each component level are technically meeting expectations of the overall end-to-end solution and are being created in time.
Work with the requirements of the end-to-end solution teams and the component development teams to assess the risks associated with the system development. This will include project risks and technical risks in software development and integration. Continuously work with the component teams to find approaches to mitigate any risk.
Engage both software and system verification and validation teams in the end-to-end solution planning efforts for functional and technical verification of software interfaces (software to software interfaces as well as software to instrument interfaces).
Be directly responsible for ensuring that externally developed software meets the integration expectations (functionally, technically, and timely) as defined by the business, software product management and software architecture/development teams.
Help define or ensure that the various software development teams have proper protocols and methodologies in place for product development to take place per specification requirements (i.e. proper mechanism/process by which software requirements are properly translated into software features).
Have direct access to engineering teams through line management or SBI leadership with the ability to influence deliverables, not just report them. Feel and be accountable for the software deliverables. Escalate delays and issues and provide mitigation plans to address them.
Guide the software team in navigating and applying the Design Control processes in order to be compliant with medical device guidelines (such as IEC 62304 FDA 21 CFR 820, ISO 13485, IEC 62366, etc)
Minimum 5+ experience leading software development projects (or similar technical project management), preferably in the medical device/biotech space.
A Bachelor's degree (in Computer Science, Engineering, or related field) is required.
Experience working in the regulated medical device environment, following Design Control procedures (such as IEC 62304 FDA 21 CFR 820, ISO 13485, etc) is required.
Experience managing the efforts of outsourced software development teams.
Practical experience as a leader in the use of modern software development methodologies / processes with an ability to direct the use of resources to meet department goals.
Knowledge of software technology industry trends, considerations, and emerging technologies.
Demonstrated ability to work well with senior leadership.
Experience leading within a matrixed organization.
Experience working in a fast-paced, dynamic environment.
Preferred: CSM and/or PMP certification.