Onkos Surgical · 1 week ago

Process Engineer

Parsippany, NJ

Full-time

Onsite

Mid, Senior Level

5+ years exp

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Responsibilities

Ensure work output is compliant with all current regulatory and quality standards.

Complete all required training in a timely fashion.

Lead the coating process development, scale-up and process validation efforts with a focus on the wet chemistry aspects of the process.

Participate in defining equipment specifications, ordering, installation, and qualification.

Drive process improvements.

Conduct Designs of Experiment.

Perform statistical process analysis.

Oversee all process validation (IQ, OQ, PQ).

Perform design verification testing.

Interface with the contract manufacturer and third-party vendors.

Create and manage chemical and process specifications.

Document and assess risk analysis via FMEA.

Generate process quality requirements.

Perform other tasks as project needs dictate.

Assist in preparing comprehensive project timelines with technical objectives and milestones.

Assist Manufacturing Engineers in developing innovative manufacturing and processing techniques.

Seek out new technologies for materials and processing through 3rd party relationships.

Qualification

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Chemical process manufacturingMedical device fieldPharmaceutical fieldOrganic chemistryMS degreeInorganic chemistryChemical engineeringChemical engineering problemsStatistically driven designs of experimentProcess scale-upProcess validationsComputer skillsSpreadsheetsWord processingDatabaseProblem-solvingInterpersonal skillsSelf-motivatedAttention to detailOral communicationWritten communicationOrthopedic