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We are currently looking for an ambitious Principal Quality Engineer, to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.
Job title: Principal Quality Engineer
Responsibilities:
Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
Develop test plans, inspect, and assess material’s compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.
Determine optimal measurement devices to perform inspections. Understand AQL tables and how to select the correct sampling rate based on quality criteria.
Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing
Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
Lead the development and implementation of visual and physical inspections of injection molded, mechanical, electrical, and packaging components to ensure they meet specifications.
Assist Quality Engineers and manufacturing personnel with calibration activities, which includes reviewing and retrieving calibrated equipment necessary for processing
Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA.
Analyzing/trending non-conformances through NCMRs and RMAs.
Assist in supplier audits and visits, as required.
Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
Support other duties as assigned by manager.
Required Knowledge/Skills, Education, and Experience
Bachelor’s degree required in Engineering, Biomedical Engineering, or Life Sciences.
Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.
Experience with new product development required.
Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.
Experience in metrology required.
Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.
Strong documentation capability for protocol and report generation and review.
Ability to communicate effectively within a technical environment.
Team player who celebrates winning together
Up to 10% travel may be required
Who we are: We are a team of more than 73,000 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 annual base pay for this position is:
Min $143,500 - Max $215,200Factors 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.
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