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SENIOR PROCESS DEVELOPMENT ENGINEER – CORNEAL IMPLANT

Senior Process Development Engineer – Corneal Implant

• The successful candidate will be responsible for process scale-up, process equipment identification, the design of process fixtures and tooling, and conducting experiments to establish process parameters and process capability for a manufacturing process for an implantable biodegradable medical device. The candidate is expected to play a major role in designing and developing a full-scale commercial production process.
• Participate in process equipment IOQ, process performance evaluation, and write validation reports
• Responsible for tech transfer to commercial production site(s)
• Involved in clinical production activities such as preparing SOPs, batch records, and hands-on GMP production
• Perform product testing, product performance verification and validation activities. Take responsibility for designing and executing experiments. Author protocol and test reports.
• Assist in Design Control activities involved with medical implant.

Excellent Salary and Benefits Package.

• The ideal candidate will be a biomechanical, biomedical, or medical engineer with 10 plus years of experiences in medical device industry.
• Strong process engineering backgrounds in contact lens or intraocular lens (IOL) industry are highly desirable.
• Strong background in mechanical engineering, CAD, and SolidWorks.
• Backgrounds in electric engineering, automation, robotics, and protein biochemistry a plus.
• Should be familiar with cGMP and working in a regulatory environment.
• The ideal candidate shall have a minimum education level of BS degree. MS, PhD preferred. Candidates with a BS degree yet strong industrial experiences will still be considered.

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job # or a link to this job.

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