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Systems Engineering Professional job in Norwood, MA

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Norwood, MA CorTech LLC

Job Ref:  353771
Employer:  CorTech LLC
Job Type:  Contract
Salary and Benefits:  60.00/Per Hour
Remote:  No

Location

City:  Norwood, MA
Post Code:  02062
Map: 

Description

JobsRUs.com. is seeking to hire a Systems engineering professional for our client in Norwood, MA!

Benefits Available!

$60.00/Hour

Shift Timings : 8 to 5

Senior Systems Engineer- Risk Management (Compliance and Risk Team)

Lead risk engineer must have the ability to complete complex planning of detailed product risk management objectives and be responsible for the Safety Risk Management Process for new IVD products and existing products in the field. In-depth design knowledge of IVD or MDD products and the compliance landscape.
This position reports directly to the Head of Compliance and Risk Management for Client Healthineers DX Point-Of-Care business unit. This position can be remote.

Responsibilities:
Risk expert across multiple product lines
Facilitation of risk assessments on new and existing IVD products as needed.
Ongoing IVDR support

Required Knowledge/Skills, Education, and Experience:
BS in related discipline (such as, biomedical engineering, mechanical, electrical)
4 years? experience in Risk Management in medical, aviation or defense.
8+ years of successful experience in related field, such as medical devices or defense
Must have experience in FMEA, Hazard Analysis, FTA experience and training
Expert knowledge of ISO 14971 and risk management in IVDR
Experience with multiple projects and previous experience designing products
Ability to facilitate risk management sessions while bringing consensus amongst a team.
Advance degree desired (i.e. biomedical engineering or STEM)
Travel may be up to 10% for this position
ref: (353771)
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