Siemens Healthineers · 13 hours ago
Sr Product Quality Engineer - Onsite
Austin, TX
Full-time
Onsite
Mid, Senior Level
$112K/yr - $155K/yr
6+ years expSiemens Healthineers is a leader in medical technology, dedicated to creating better outcomes and experiences for patients worldwide. They are seeking a Sr Product Quality Engineer to lead quality assurance protocols and support manufacturing operations by ensuring compliance with safety and regulatory standards, conducting technical projects, and driving process improvements.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
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
Qualification
Required
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)
Preferred
Lean Six Sigma Green Belt or higher, preferred
Benefits
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
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Anton Ebert
Technology Focus Topic Lead - Digital Twinning
Recent News
2026-01-21
Company data provided by crunchbase