Systems Engineer, Staff

Hoffman Estates, Illinois
18 Oct 2016
24 Nov 2016
Oil and Gas
Contract Type
Full Time
Division Healthineers
Job Type Regular

Business Unit DI MI - Molecular Imaging
Job Time Full-Time

Functional Area ENG - Engineering
Experience Level Mid Level

Req ID 159443
Required Education Bachelors Degree

Location IL - Hoffman Estates
Required Travel 20%

Division Description
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world's largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers' needs. So that more people can have a life that is longer, richer, and more filled with happiness.

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Job Description
The Molecular Imaging (MI) division of Siemens Healthcare (Hoffman Estates, IL facility) is currently seeking a Staff-level Compliance Engineer to join our PET and SPECT engineering teams to develop the next generation of molecular imaging devices (  The ideal candidate should have experience in of FDA Quality System Requirements, IEC 60601-1, RoHS, REACH, ISO 13485 and CMDR Quality System Requirements for advanced hardware and software systems. This position will work across a cross-functional, multi-site organization with large and diverse teams, acting in a technical leadership role. The primary function of this role will include the compliance engineering with applicable standards and the testing of these standards for molecular imaging devices in the PET/CT, SPECT and SPECT/CT product lines. A deep understanding of applicable standards with the ability to translate the standards into product requirements is required.  A passion for delivering products that improve the outcomes of patient healthcare is essential for membership on our team.

• Write and drive engineering level compliance requirements, specifications, verification testing protocols and product certifications in accordance with US FDA, EU Medical Devices Directives, CE, UL, etc.
• Ensure seamless integration of new standards for complex hardware and software systems that are designed and manufactured at multiple locations across the globe
• Prepare documentation for medical device design projects and communicate with internal regulatory affairs personnel to support global clearances/approvals.
• Work with internal regulatory affairs department to ensure proper labeling and to maintain CE, NRTLs, RoHS, REACH, IEC 60601-1and EMC, etc. technical files.
• Review product and manufacturing changes for compliance with applicable regulations plus validate testing reports for completeness and accuracy.
• Coordinate certifications and demonstrated testing required for international product releases. (China, South Korea, Brazil, Russia, etc.)
• Perform and oversee compliance testing to the standards
• Collaborate with design teams to resolve compliance issues

Required Knowledge/Skills, Education, and Experience

• Extensive 5+ years experience with compliance engineering including 3+ years experience with medical devices
• Bachelor degree or greater in Electrical Engineering or related field
• 8+ years of direct engineering experience with complex products
• Strong interpersonal, written and verbal communication skills to convey ideas and concepts to a wide range of international audiences (USA, Germany, China & India)
• Positive attitude team player with ability to also work autonomously
• Ability to work in a fast-paced, deadline-oriented environment
• Domestic and occasional international travel required (20%)

Preferred Knowledge/Skills, Education, and Experience

• Understanding and knowledge of typical regulatory requirements, international regulatory issues, industry best practices and certification processes.
• Demonstrates the ability to manage change in rapidly evolving situations
• Experience with developing and executing system level verification tests
• Comprehensive knowledge of system design principles
• Experience with 510K medical devices.

Siemens encourages qualified long-term unemployed individuals to apply for open positions.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

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, disability status, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law:
Applicants and employees are protected under Federal law from discrimination. Click here to learn more.

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