Product Quality Engineer

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Varian, a Siemens Healthineers company is seeking a dedicated and detail-oriented Product Quality Engineer to join our team in Palo Alto, California. In this position, you will play an instrumental role in engaging with our local and global partners, driving various transformation initiatives and providing daily support to our manufacturing operations.

***This onsite position is primarily based in Palo Alto, California with some support (~15%) in San Jose, California***

In this role, you will mainly be responsible for the following:

• Designing, generating, implementing and maintaining quality assurance and quality control protocols, standard operating procedures and methods for inspecting and processing materials into partially finished or finished products
• Providing engineering support for designing and conducting research/technical projects and contributing to the identification of appropriate methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products
• Assisting engineering in evaluating and defining requirements for automated manufacturing and testing integrated systems and processes
• Providing engineering support to manufacturing and conducts the evaluation and disposition of nonconforming product and process related issues using a risk-based approach to resolve problems impacting production fulfillment
• Providing all planning necessary and reviewing production schedules with cross-functional teams to ensure effective product acceptance based on the Device Master Records
• Spending time on the manufacturing floor to determine process improvements, participating in investigations, root cause analyses, corrective action planning, implementation activities and interfacing with all cross functional departments to increase product quality using recognized Six Sigma and Lean methodologies
• Ensuring compliance with internal and external safety, quality and regulatory standards requirements (e.g. Food and Drug Administration, International Organization for Standardization) by reviewing and approving product and quality system changes with Engineering and Manufacturing
• Participating in Quality Review Boards, performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates or changes to quality standards and procedures when necessary
• Executing New Product Introduction/Design Transfer activities in characterizing manufacturing processes for parts/components in development to ensure smooth transition from Research & Development to manufacturing, including participation and leadership of the development of equipment and process validation requirements (Failure Modes and Effects Analysis, Installation Qualification, Operational Qualification, Performance Qualification), using appropriate statistical tools and techniques
• May be involved in/lead activities related to the implementation and effectiveness of the equipment calibration program, such as: authoring, revising and maintaining equipment related procedures, work instructions and forms; creating, modifying and maintaining equipment calibration requirements; advising instrument owners/departments on calibration related issues; assisting cross-functional engineering groups in investigating equipment non-conformances and out of tolerance results; leading and/or contributing to system and process improvement projects; etc.

Minimum Required Skills and Knowledge:

• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.

Typical Education and Experience:

• Bachelor's degree in Engineering and 2-5