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, 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.
Job Title: Risk Manager
Location: Berkeley, CA - work remotely is possible
To ensure that risk management for Siemens Healthineers Molecular system and Software products are effectively deployed and sustained.
Specific responsibilities include:
- Risk Coach and Trainer
- Apply system and software product knowledge to risk management activities within the Specialized Molecular R&D group (e.g. Product specific Risk Plan, FMEA, Risk Report)
- Member of the Molecular product health team with responsibility to perform periodic post-production risk assessment
· Ensure product line risk files are updated per defined schedules and to align with changes to external or internal risk guidance
- Advise R&D personnel on risk management activities throughout the product lifecycle. This includes risk management plans and reports, hazard analysis, design and process risk assessment
· Advise R&D personnel on risk management associated with Corrective & Preventive Actions (CAPA)
· Drive continuous improvement efforts through facilitating, leading and collaborating with cross functional teams
- Represent R&D during internal and external audits on matters related to risk management
- Keep abreast of emerging regulatory/industry trends regarding risk management
- Additionally support team projects as needed (e.g. Quality required documentation support)
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 10 years in the diagnostics industry with at least 5 years of demonstrated experience and proficiency with systems and software development. A minimum of 3 years demonstrated experience with Risk Management.
- Excellent understanding and practical application of medical device quality system regulations, in particular ISO 14971.
- Excellent verbal and written communication skills
· Strong interpersonal skills and ability to lead teams
· Excellent problem solving skills
· Ability to understand and apply system and software product knowledge
· Ability to recognize problems and take corrective measures
· Experience with risk management processes and tools
· Experience with in vitro medical devices
· Ability to query and analyze technical, scientific and medical information
· Ability to communicate results and propose recommendations to a technical audience of varying skill levels
· Excellent project management skills
· Ability to manage multiple ongoing tasks, be responsive to critical situations and changing priorities
· Ability to work independently; self-motivation is a must
Preferred additional Knowledge/Skills, Education, and Experience
· Ability to understand and apply assay product knowledge. Assays run on systems and use software.
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.