Sr Product Quality Engineer - Onsite

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Varian Medical Systems, a Siemens Healthineers company is hiring for a Sr Product Quality Engineer. In this role you will be on-site to lead the efforts in designing, implementing, and maintaining quality assurance protocols and methods for processing materials into subassemblies or finished products. 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 role is designed to be onsite Monday-Friday day shift in Austin, TX** What You will do: Actively ensure 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. Provide 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. Provide engineering support to our local manufacturing and quality partners for the evaluation and disposition of nonconforming product and process related issues using a risk-based approach to resolve problems. Spend 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 Lead and participate in 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. Assisting engineering in evaluating and defining requirements for automated manufacturing and testing integrated systems and processes Experience with process and software validation and the ability to develop and write protocols, validation reports, engineering reports, etc. that support product development and manufacturing process changes in compliance with design controls. Active participation and decision making throughout the product life cycle (e.g., engineering changes, end-of-life, etc.) to assure that adequate quality assurance requirements are met, risks are thoroughly assessed and mitigated, and designs are adequately transferred into manufacturing with high process capability measured against critical to quality design output requirements. Execute 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. What You will have: Bachelor’s degree in engineering (mechanical or electrical preferred) or equivalent experience and 8 years of related experience or master’s degree with 6 years of related experience in the medical device industry. Proven experience working with and understanding Quality System requirements in the medical device industry, such as 21CFR820, ISO 13485:2016, EU MDR. Knowledge and experience with electro-mechanical products that use software/firmware as well as knowledge and experience with manufacturing processes (e.g., chemical (preferably embolics), welding, injection molding, machining, sterilization). Experience with manufacturing engineering and/or process engineering, desired. Experience with SAP or equivalent ERP and productivity software. One or more quality certifications required (e.g. ASQ – CQE, CQA, CBA). Lean Six Sigma Green Belt or higher, preferred. #LS-OS1 Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $112,420 - $154,572 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, intervie