Development Process Engineer II

Job description

·  Job facts

Summary

Roche Sequencing Solutions (RSS) is building on Roche's legacy of innovation to transform next-generation sequencing and its application. The RSS Development Process & Support team is an internal-customer support organization that creates, manages, and improves processes, labs, and infrastructure to support product development teams.

The RSS Development Process & Support team is in need of a Development Engineer II who will participate in the development of assay and system products and the application of design control processes. The role involves conducting studies and experiments in a sequencing laboratory environment. In addition, the individual will provide subject matter expertise to internal R&D teams on best practices, methods, and tools pertaining to IVD product development, design control, and documentation.

Responsibilities

·  Applies development processes in the research and development of new products
·  Conducts experiments and formal Development studies in the laboratory.
·  Guides engineers and scientists in RSS on best practices for design control process and how they can apply them in their projects
·  Responds to staff questions and inquiries with clear communication, professionalism, and positivity
·  Provides expertise and critical analysis for Design Control deliverables such as risk and requirements management, verification and validation, and design change control.
·  Manages and supports product development and design control processes, including authoring Standard Operating Procedures and templates and resolving questions about their application
·  Develops training content in the form of presentations, process maps, documentation guidance, and website content
·  Supports scientific and engineering user group in the useage, training, development and maintenance of engineering and application lifecycle management software tools
·  Performs work according to established internal safety guidelines and procedures
·  Applies technical principles, tools and knowledge gained from previous work experience to tackle challenges of complexity and diversity of scope
·  Works under general supervision (plans and executes own work, is comfortable taking actions and making decisions within the scope of the role)
·  Works on a wide range of problems where original contributions are required. Creative, imaginative thinking is required.
·  Delivers a high quality, thoughtful work product with consideration for multiple stakeholders, including business, regulatory, quality, and product development needs.

Knowledge, Skills and Abilities

·  Has technical product development experience and knowledge of design control processes, experimental design, versatile laboratory practice, data analysis, and data and concept presentation
·  Ability to adopt a customer-support mindset (clear, professional, and positive communication)
·  Organized and detail-oriented
·  Excellent writing and editing skills

Qualifications

Bachelor's degree in Engineering, Scientific, Quality, Regulatory or related field

Required BS or equivalent with 2-6 years related experience or MS with 2-3 years related experience or Ph.D. degree; preferred MS with 3+ years related experience plus,

·  Formal training in Agile development, Scrum, and/or Kanban methods desirable
·  Formal training in System Engineering highly preferred
·  Experience in medical device industry and training in IVD design control processes highly preferred

Knowledge, Skills and Abilities

·  Has technical product development experience and knowledge of design control processes, experimental design, versatile laboratory practice, data analysis, and data and concept presentation
·  Ability to adopt a customer-support mindset (clear, professional, and positive communication)
·  Organized and detail-oriented
·  Excellent writing and editing skills

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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .

·  Who we are

At Roche, 98,000 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.