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Medical Device Validation Engineer - Blue Ash, OH(Onsite) - Contract at Remote, Remote, USA
Email: [email protected]
From:

Sandeep Gautam,

Siri Info Solutions

[email protected]

Reply to:   [email protected]

Hello,  

Hope you are doing great.

This is Sandeep Gautam, a recruiter working with Siri Info Solutions. Trying to reach you regarding the below job position please have a look at the job description

Please go through it and if you are comfortable with this role, reply to this email with your updated resume.

Position:
   Medical Device Validation Engineer

Location:
  Blue Ash, OH(Onsite)

Duration:  Contract

Job Description:

Experience in development of medical device components, building device assemblies and instruments.

Change control in a regulated environment (preferably medical device)

Experience in Plastic/Metal Injection molding

Experience in resolving injection molding problems.

Manufacturing and process development experience

Experience with assembly techniques and equipment technologies

Process validation (GMP)

Statistical process control / capability analysis

Measurement system analysis, including GR&R

Risk analysis, including use of FMEA

Engineering drawing interpretation including GD&T fundamentals

Know- how about Product Life Cycle Management

Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements

Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities)

Experience on equipment/ tool development and qualification

Good knowledge in design program/project approach and governance

Experience in Design verification and Validation

Knowledge of statistical analysis and its applicability to derive engineering rationale

Knowledge of change management plans

Preferred experience with design, engineering and functioning of surgical devices

Development & Conduct of Engineering /Test Studies

Experience in Process Qualification (IQ/OQ/PQ) and Factory Acceptance Testing

Knowledge of Design of Experiments or Process Characterization

Experience in different manufacturing and assembly process, DFMA principles

Experience in custom fixture/gauge design/Fail proof principles

Exposure to trouble shooting and root cause analysis

Preferred experience in process improvement strategies to improve efficiency and throughput

Exposure in automation involving pneumatics/hydraulics/PLCs

Exposure to Optical Vision based measurement systems

Exposure to Software requirements Development for assembly equipment

Knowledge of Ergonomics and Safety requirements in equipment design

Thanks and Regards,

Sandeep Gautam

Team Lead(Recruitment)

Siri InfoSolutions Inc, 3 Ethel Rd, Suite # 302, Edison NJ 08817

Ph. No:

848-800-0911

Ext: 3121

Mail Id:

[email protected]

LinkedIN -

linkedin.com/in/sandeep-gautam-731526166

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Medical Device Validation Engineer - Blue Ash, OH(Onsite) - Contract
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Wed Sep 18 04:10:00 UTC 2024

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