Medical Device Testing
Apply NowCompany: AA2IT
Location: West Point, PA 19486
Description:
Title: Engineer II - Medical Device Testing
Rate: $43/HR
Location1:770 Sumneytown Pike, West Point, PA 19486
Location 2: 126 E. Lincoln Avenue, Rahway, NJ 07065
Must have : Design Control Experience
Technical writing
Injectable Product is plus plus
Qualifications:
Education: Bachelors in Science, Engineering or related field.
Can be a mix of Co-op and real world experience (3-5+ years).
Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971.
Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management.
The candidate will work with a small team that supports life-cycle management activities of medical device combination products.
Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
Proven problem solving abilities. Demonstrated written and verbal communication skills.
Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management.
Responsibilities:
The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices.
Comments/Special Instructions
Perfect Candidate has more life cycle management activity experience (change control, technical writing, etc) not research. Small project management skills, good communication, technical writing. Medical device background/experience, understanding root cause, deviation management and change management
Kindly share your resume with answers:
Q1: how many years of exp in Medical Device Design Control Exp
Q2: How many years of exp in Technical Writing / change control
Q3: Which year you completed your Bachelors
Q4: Which location would you like to work a) Rahway NJ b) West Point PA
Rate: $43/HR
Location1:770 Sumneytown Pike, West Point, PA 19486
Location 2: 126 E. Lincoln Avenue, Rahway, NJ 07065
Must have : Design Control Experience
Technical writing
Injectable Product is plus plus
Qualifications:
Education: Bachelors in Science, Engineering or related field.
Can be a mix of Co-op and real world experience (3-5+ years).
Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971.
Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management.
The candidate will work with a small team that supports life-cycle management activities of medical device combination products.
Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
Proven problem solving abilities. Demonstrated written and verbal communication skills.
Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management.
Responsibilities:
The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices.
Comments/Special Instructions
Perfect Candidate has more life cycle management activity experience (change control, technical writing, etc) not research. Small project management skills, good communication, technical writing. Medical device background/experience, understanding root cause, deviation management and change management
Kindly share your resume with answers:
Q1: how many years of exp in Medical Device Design Control Exp
Q2: How many years of exp in Technical Writing / change control
Q3: Which year you completed your Bachelors
Q4: Which location would you like to work a) Rahway NJ b) West Point PA