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Posted: Thursday, January 4, 2018 3:07 PM


Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Staff Engineer Risk Management: Part time position 20 hours a week
YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Staff Engineer Risk Management, are to:

:
Provide leadership and development / support of Bayer Radiology Risk Management deliverables in accordance to Bayer Radiology Risk Management procedure;
:
Safety Risk Management Plans
:
Device Safety Characteristic Documents
:
Development Safety Plans
:
Hazard and Harm Identification Documents
:
Design Risk Evaluation Documents
:
Verification and Validation Risk Evaluation Documents
:
Safety Risk Management Reports
:
Post Market Surveillance Reports
:
Health Risk Assessments
:
Post Market Benefit Risk Assessment
:
Risk Assessment Support Documents
:
Product Safety Risk Assessment
:
Detailed Design Failure Analysis
:
Process Failure Analyses
:
Technical Evaluation
:
Develop and maintain consistent/best:in:class lifecycle
Risk Management policies, procedures and practices;
:
Engage in active cross:functional teamwork and collaboration with System Engineering, Engineering/LCE, Issue and Complaint Management, Medical and Clinical Affairs, Regulatory Affairs and Safety Review Board relative to Risk Management deliverables and support in accordance with the Radiology Risk Management procedure.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

:
Bachelors Degree in Engineering with a minimum of 7:10 years of experience;
:
Familiarity of Human Factors engineering methods within medical devices industry (IEC 62366);
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Familiarity with software safety in medical devices industry (IEC 62304);
:
Familiarity with IEC 60601:1 3rd edition;
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Excellent communication skills (verbal and written);
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Strong leadership skills;
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Strong cross:functional ability;
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Self:motivated/self:directed/self:learner;
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Continuous improvement focus;
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Ability to handle multiple priority items at the same time.

Preferred Qualifications:
:
3 years experience in life:cycle Risk Management support in medical device industry (ISO 14971);
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3 years experience developing Risk Management deliverables;
:
Understanding of Design Control requirements in the medical device industry;
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Experience with medical device New Product development;
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Experience with Post Market Surveillance support associated with medical devices;
:
Solid foundation in quality engineering methods/tools.

*This position is part:time (20 hours per week)

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Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Application Period:
Posted until 10/31/17
Reference Code:
7597
Division:
Pharmaceuticals
Location:
United States : Pennsylvania : Indianola
Functional Area:
Engineering
Position Grade:
VS 1.1
Employment Type:
Regular
Work Time:
Salaried; non:exempt; part time position 20 hours per week
Contact Us
Address
Telephone
E:Mail
Pittsburgh, PA
+1

Source: https://www.tiptopjob.com/jobs/76617183_job.asp?source=backpage


• Location: indianola, Pittsburgh

• Post ID: 60429532 pittsburgh
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