Sr Product Quality Engineer - Onsite

Siemens Healthineers; Austin (TX); On-site; USD 112,420 - 154,572; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Paid time off

Job summary

Dormont Manufacturing Co in Austin, Texas, is looking for an experienced engineer to ensure compliance with safety and quality standards in the medical device industry. Responsibilities include providing engineering support for production processes, leading data analysis, and executing new product introduction activities.

A Bachelor’s degree in engineering and substantial experience in the medical sector are required. The role offers a competitive salary range and comprehensive benefits, including medical and dental insurance.

Qualifications

• 8 years of experience in the medical device industry or a Master's degree with 6 years of experience.
• Experience with process and software validation.
• Quality certifications like ASQ – CQE, CQA, CBA required.

Responsibilities

• Ensure compliance with safety and quality standards.
• Support research projects and evaluate production processes.
• Lead data analysis and statistical methodologies.

Skills

Quality System requirements understanding

Electro-mechanical product knowledge

Manufacturing engineering experience

SAP or equivalent ERP experience

Lean Six Sigma Green Belt

Education

Bachelor’s degree in engineering

Job description

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 Mode 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.

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 Affimative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to 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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Export Control:

"A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

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