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About the Role
Accountable for design and development processes, ensuring adequate quality controls and documentation throughout the product realization stages. This role requires a commitment to quality due to the safety-critical nature of medical devices and involves collaboration with global teams.
Responsibilities
- Ensure compliance requirements are met according to applicable regulations, directives, and standards, including 21CFR part 820 - QMSR, EU MDR regulation 2017/745, ISO 13485, and the company quality manual.
- Ensure close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant.
- Review the design and development documentation for adequacy and ensure that they are consistent with the company wide, global processes.
- Support, evaluate, and monitor that the required verification and validation processes are performed and documented.
- Stay involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage.
- Define and ensure that statistical data is collected and analyzed.
- Support and evaluate engineering teams with root cause analysis and corrective actions implementation.
Requirements
- B.S. degree in a related field (Mechanical Engineering, Electrical Engineering, Chemical Engineering, or Chemistry) and 7+ years of related experience in medical device (preferred) or pharmaceutical industry OR M.S. Degree with 4+ years of related experience
- Experience in product development or in design quality assurance in medical devices or in other regulated industry
- Ability to work with international standards and regulations applicable to medical devices
- Previous work experience in controlled environments and cleanrooms
- A successful candidate must be able to work with controlled technology in accordance with US export control law.
Skills
- Advanced statistics
- Process control
- Design of experiments
- Understanding of chemical manufacturing
- Basic laboratory skills
- Communicative
- Focused
- Analytical
- Ability to express ideas and research in written form
- Ability to work independently
- Open to discussing ideas and solutions with colleagues
- Thrive in an international work environment
- Cultivating contacts with partners in North America and overseas
Location
- Austin, TX
Work Type
- Full-time
Experience Level
- 7+ years of related experience
- 4+ years of related experience
Education Level
- B.S. degree in a related field
- M.S. Degree
- ASQ Certified Quality Engineer or Certified Reliability Engineer (Preferred)
Salary/Compensations
- $112,420 - $154,572
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
About the Company
- A team of more than 72,000 highly dedicated Healthineers in more than 70 countries.
- A leader in medical technology, constantly pushing the boundaries to create better outcomes and experiences for patients.
- Portfolio is crucial for clinical decision-making and treatment pathways.
- A global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas.
- 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.
Equal Opportunity
- 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.
- Applicants and employees are protected under Federal law from discrimination.
- Siemens Healthineers is committed to equal employment opportunity.
- As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.