Back

Risk and Safety Management Engineer

Job Description

sh_logo_compact_cmyk_52mm.jpg

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as a Risk and Safety Management Engineer

Job Location: Flanders, NJ or Tarrytown, NY or Newark, DE

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Risk and Safety Management Engineer, you will be responsible for:

·         Owning risk management activities throughout the life cycle of the product.

·         Partnering with product teams to create, manage, and maintain product risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements.

·         Working independently and collaboratively to drive the appropriate activities such as leading and facilitating risk identification, assessment, and controls, guiding risk-based product and manufacturing process development, updating risk management files based on post-market feedback, and utilizing quality system data to make risk based decisions to ensure product safety.

  • Contributing to development and maintenance of compliant risk management systems, procedures and practices and be responsible for the Risk Management File portion of the product Design History File.

·         Applying techniques for generation of risk management documentation, e.g., PHA, FTA, FMEA, HAZOP, with the support of the design team.

·         Partner with subject matter experts in the development, maintenance and promotion of risk management processes for medical devices, including managing and maintaining policies and procedures.

·         Execute changes to Risk Management Files due to changes in standards, regulations, post market feedbacks, or industry best practices.

·         Ensure consistency of Risk Management Files across product lines.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

  • A minimum of 8-10 years’ experience with product risk management processes (medical device industry is a plus)
  • Strong analytical and organizational skills, flexibility, and attention to detail
  • Knowledge of medical device product design and development processes
  • Strong communication skills with experience working independently and on cross-functional teams
  • Excellent PC skills (MS Office software Word, PowerPoint, Excel, Visio and Outlook)

Required skills to have for the success of this role

  • Bachelor’s degree in engineering, biology, chemistry or related field.
  • Practical knowledge and experience with ISO 14971:2019 required
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803 and 820, ISO13485, IEC 62304, IEC 62366-1, and European Medical Device Regulations (MDR) 2017/745.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens 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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?