Siemens HealthineersBusiness Unit:
Laboratory DiagnosticsRequisition Number:
United States-Delaware-NewarkAssignment Category:
Full-time regularExperience Level:
Mid levelEducation Required Level:
Bachelor's DegreeTravel Required:
This position is responsible to provide direction in the areas of Design Controls to cross-functional teams responsible for new product development or design changes. As a Subject Matter Expert (SME), the individual must be able to lead some improvement projects and training on the elements within Design Controls.
This is a Siemens Healthineers Diagnostics, Laboratory Diagnostics, Quality, Medical, Biostatistical and Design Quality, organization position reporting to the Director of Assay Design Quality Engineering.
Principle Duties and Responsibilities (essential functions)
• Will provide guidance for application of design controls in accordance with regulatory expectations as a member of the Core Team or Design Change Team
• Assists in leading deployment of quality engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Utilizes of quality engineering principles and problem solving skills (risk analysis and problem solving methodologies, statistical techniques, etc) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
• Provides guidance, recommendations, and implementation plans for adherence to regulatory requirements or expectations related to Design Controls, risk Management, quality engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)
• Assist in ensuring the development of compliant verification and validation plans and reports for products and processes.
• Assist in ensuring the compliant development and validation of appropriate test methods for product and process performance.
• Will assist in ensuring active and thorough investigation of quality issues and effective corrective and/or preventive action.
• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results.
• Participates in regulatory inspections.
Required Knowledge/Skills, Education, and Experience
At a minimum, a BA/BS degree (Life Science, Chemistry, Physical Science or Engineering).
Other Skills and Abilities:
A DQE 3 demonstrates a well-developed knowledge of design quality engineering principles and a record of successful completion of assignments. This includes in-depth knowledge of ISO 13485, and FDA Quality System Regulations. Typically 3-5 years of successful experience in a quality, assay development or manufacturing role in the IVD industry or related field and successful demonstration of Principle Duties and Responsibilities.
Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project).
Effective communication and collaboration skills.
Effective technical writing.
Sense of urgency, intellectual curiosity, prudent risk-taking.
Travel: Occasional overnight travel may be required with less than 10% of time.
Certifications, Licenses, Registrations:
Certified Quality Engineer (ASQ CQE, CRE or equivalent); preferred.
Green Belt or Black Belt certification preferred