Principal Design Control Systems Engineer I

Job description

  Job facts

Position Summary:
The Principal Design Control Systems Engineer I of Design and Development Process oversees the management of Roche Sequencing Solutions product development and design control processes, development laboratory processes and documentation, supports engineering and application lifecycle management software tools, and provides trainings to support multiple Roche Sequencing Solutions (RSS) sites and product development teams.

The team will provide subject matter expertise to development scientists and engineers on the best practices, methods, and tools pertaining to IVD product development, design control, and documentation.

The successful candidate is a confident, hands-on leader with organizational savvy, a professional communication style, and demonstrated team building and influencing skills.

Essential Functions:

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Leads technical activities in an area of specialty

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Communicates results to management via written reports and oral presentations.

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Works on a wide range of problems where original contributions are required. Creative, imaginative thinking is required

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Plans Systems Development project activities and determines technical objectives

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Recommends new or creative approaches for Product Development and Development Tools

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Develop, communicate, and implement a strategic vision in alignment with the goals of the RSS organization

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Serve as a subject matter expert on theories and best practices pertaining to IVD product development, design control, and documentation

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Manage and execute projects, resources, and initiatives associated with writing, reviewing, and/or revising standard operating procedures (SOPs) and documentation procedures, templates and standards

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Implement initiatives to harmonize processes and quality management systems in collaboration with other business areas

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Ensure process and documentation deliverables generated by the team are thoughtfully conceived and well-written

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Manage and execute projects, resources, and initiatives associated with implementation of lifecycle management tools

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Develop and tailor processes to suit new and emerging technologies, finding solutions that are both practical and consistent with quality and compliance needs

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Develop and deliver training and coaching in application of product development processes and documentation templates, including creation and implementation of design history files, requirements management, risk management, configuration management, design change control, verification documentation, defect management, and CAPA

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Contribute to the strategy, implementation, and maintenance of all tools and processes that support department efficiency and standardization

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Identify and oversee the development of requirements and processes to support global standards and regulatory compliance for technical documentation

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Facilitate audits of development processes, activities, and documentation.

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Establish effective task management processes enabling team performance metrics and dashboards

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Effectively and professionally represent the organization and the company

Required Skill Set:

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Excellent presentation and communication skills

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Ability to work independently as well as on a team

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Ability to direct team

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Organizational skills to work with a large amount of information and to cope with rapidly changing information

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Applies advanced technical knowledge to multi-disciplinary projects

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Must be a self-Starter

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Ability to articulate technical topics to non-technical individuals

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Ability to contribute to multiple projects/demands simultaneously

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Makes major contributions to strategic directions and projects through knowledge of Development Processes and Development Tools

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Advanced in Systems Thinking

Formal Training/Education and Experience:

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Bachelor's degree in System Engineering, Bioengineering, System Engineer, Regulatory Affairs + 10 years of related experience or equivalent combination of education and work experience;

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OR Master's degree in System Engineering, Bioengineering, System Engineer, Regulatory Affairs + 8 years of related experience;

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OR Ph.D. degree in System Engineering, Bioengineering, System Engineer, Regulatory Affairs + 5 years of related experience.

Preferred:

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Knowledge and experience in ISO, CLIA, GxP, FDA, CE and other regulatory compliance requirements.

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Demonstrated capability in functional leadership, e.g. personnel management, organizational change management

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Excellent writing / editing skills

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Project management experience, Agile, KANBAN

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Professional education, license, or certification in Biotechnology, Bioscience Business, Regulatory Affairs, Information Management, Product Development, Agile Development, Project Management, Design Control, QSR, or RAPS

Other:

·  Must be able to travel frequently between RSS Santa Clara and Pleasanton

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.