Sr. and Pr. Engineer (JPI2323 and I2324) - Alpha Professional Resources, A.P.R., Inc.
Company Description:
Job Description:
Position title:
Sr.
and Pr.
Engineer (JPI2323 and I2324) Duration:
Contract 12 :
18 months
Responsibilities:
:
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
:
Create and execute to project plans and schedules Education:
:
BS in Engineering (Mechanical preferred) and previous experience in a medical device industry :
5:
10 years current experience with engineering processes and procedures.
Skills:
Led projects from development through the 510k and PMA approval process.
:
Strong background in engineering and commercialization of electro:
mechanical medical devices.
:
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) and US (FDA/PMA/510k) submissions.
:
Experience in drug/device combination product design and development :
Familiar with the following standards:
o Quality System Regulation :
21CFR820 o Risk Management :
ISO 14971 o EU Medical Device requirements :
Council Directive 93/42/EEC o Medical Electrical Equipment :
EN 60601 :
Small scale device assembly experience.
:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
:
Strong problem solving, risk assessment, and risk management skills.
:
Must be capable of working on multiple projects in a deadline driven environment.
Source:
http:
//www.
tiptopjob.
com/jobs/28550704_job.
asp?source=trovit.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
Position title:
Sr.
and Pr.
Engineer (JPI2323 and I2324) Duration:
Contract 12 :
18 months
Responsibilities:
:
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
:
Create and execute to project plans and schedules Education:
:
BS in Engineering (Mechanical preferred) and previous experience in a medical device industry :
5:
10 years current experience with engineering processes and procedures.
Skills:
Led projects from development through the 510k and PMA approval process.
:
Strong background in engineering and commercialization of electro:
mechanical medical devices.
:
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) and US (FDA/PMA/510k) submissions.
:
Experience in drug/device combination product design and development :
Familiar with the following standards:
o Quality System Regulation :
21CFR820 o Risk Management :
ISO 14971 o EU Medical Device requirements :
Council Directive 93/42/EEC o Medical Electrical Equipment :
EN 60601 :
Small scale device assembly experience.
:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
:
Strong problem solving, risk assessment, and risk management skills.
:
Must be capable of working on multiple projects in a deadline driven environment.
Source:
http:
//www.
tiptopjob.
com/jobs/28550704_job.
asp?source=trovit.
Estimated Salary: $20 to $28 per hour based on qualifications.
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