Regulatory Systems Engineer

Hoffman Estates, Illinois
04 Oct 2016
22 Oct 2016
Oil and Gas
Contract Type
Full Time
Division Healthineers
Job Type Regular

Business Unit AT - Advanced Therapies
Job Time Full-Time

Functional Area ENG - Engineering
Experience Level Senior Level

Req ID 158166
Required Education Bachelors Degree or equivalent experience

Location IL - Hoffman Estates
Required Travel 8%

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.

For more information, please visit:

Job Description
The Advanced Therapy (AT) division of Siemens Healthineers is looking for a
technology driven regulatory expert to join our Cardiology Solutions department
as a Staff Regulatory Systems Engineer at our Hoffman Estates, IL facility. This
department develops hemodynamic and electrophysiological recording systems as
well as billing and reporting tools for the Cardiac Catheterization lab.

Position Description: The Regulatory Systems Engineer serves
as the regulatory expert to support the development team during the product
development lifecycle. You will analyze regulatory requirements, ensure accurate
interpretation, and develop derived requirements for our products. You will also
oversee and guide regulatory certification and testing of our products. The
Regulatory Systems Engineer is involved throughout the entire product
development life cycle to ensure the product meets all regulatory requirements.

The following are specific responsibilities of the Regulatory Systems

  • Review, assist in the development and implementation of relevant SOPs
    related to medical device vigilance, product complaint, design controls,
    medical inquiries, process validations, etc.

  • Work with stakeholders to identify and assess product risks (frequency,
    certainty, severity, and mitigations). Recommend, convince, and implement
    the most pragmatic solutions.

  • Work with regulatory team and external test houses to ensure that
    products and processes meet all applicable required regulatory and safety

  • Review Design History Files and Technical Files for conformance to
    applicable requirements.

  • Resolves non-compliance issues; recommend product and/or process
    changes; initiate engineering change orders.

Required Knowledge/Skills, Education, and Experience:

  • Bachelor's Degree in Engineering or Scientific Discipline + 8 years'
    professional experience OR

  • Master's Degree in Engineering or Scientific Discipline + 6 years'
    professional experience

  • Experience in statistical analysis and tools

  • Experience with application of quality regulations (e.g. CFR 21 820 FDA
    Quality System Regulation, cGMP, ISO 14971 Risk Management, ISO 13485, EU
    medical Device Directives, etc.)

  • Knowledge of standards, including IEC, UL, ISO 60601-1, IEC 60601-1-2,
    IEC 60601-2-25, IEC 60601-2-49

  • Knowledge of Hazardous Substance Regulations (Rohs, REACH, WEEE, etc...)

Preferred Knowledge/Skills, Education, and Experience:

  • Experience in technical writing (e.g. investigations, engineering change
    requests, SOPs, protocols, etc.)

  • Excellent interpersonal, written and verbal communication skills to
    communicate information effectively to marketing, managers, and technical

  • Ability to convey ideas and concepts to a wide range of audience
    including the clinical community, product management and engineers is

  • Ability to discuss problems and negotiate solutions with product
    management and engineering team.

  • Ability to work in a fast-paced, deadline oriented environment as part
    of a team is required.

  • Strong analytic and decision-making skills.

  • Strong quality orientation and customer focus.

  • Occasional domestic and international travel required.

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.