Summary: The Process Engineer II is responsible for developing, implementing, and troubleshooting new methods used in manufacturing in support of the release of new products. This individual will assist in design, development, and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. This individual may establish operating equipment specifications and improve manufacturing techniques. In addition, this individual is involved in new product development, process improvement, and design transfer activities, and may serve as a Process Development lead on project teams. Requirements: At least 4 years of industry experience in process development or product development and technology transfer Understanding of product development lifecycle (development, V&V, design control, design transfer, sustaining support) Experience with life science research tools process development Experience working with RNA/DNA/Protein/Antibody assays and protocols Experience working with robotics such as the nCounter instrument or liquid handling systems Excellent technical writing and record-keeping abilities Experience with GMP or ISO production and batch record review Experience with ISO and FDA process development standards and principles including definition of critical process parameters and critical quality attributes Excellent analytical skills and familiarity with statistical analysis software such as JMP, Minitab, R, etc. Demonstrated experience with Design-Of-Experiments (DOE) and associated analysis
• Develop methods for the manufacturing and use of NanoString products • Develop and draft SOPs, Batch Records, Specifications, and other documentation associated with process transfer to a Manufacturing environment • Assist with performing and documenting Risk Assessments • Assist with design, document and summarize Verification and Validation studies • Draft protocols, experimental summary reports, quality documents and other scientific literature associated with projects • Work cooperatively in a timeline-focused, matrixed, team environment • Present data to product/process development teams and management representatives • Analyze large, complex data sets using spreadsheets and/or other data analysis packages
• Ph.D. or M.S. in related life science discipline highly preferred. B.S. with direct work experience will be considered.• Familiarity with ISO 13485 or working within QSR environments preferred • Experience in Risk Management and performing Risk Analysise.g. FMEAs preferred • Comfortable working within electronic quality management systems (EQMS) e.g. MasterControl preferred
NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.