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Validation & Engineering Group, Inc. · 1 month ago

MF02-112425 PD Engineer for Medical Devices

Dorado, 051

Full-time

Onsite

Mid, Senior Level

3+ years exp

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Medical Devices. The Process Development Engineer will develop and review documentation, support automation systems testing, and manage process development projects to ensure effective manufacturing processes.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products

Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities

Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures

Design and develop in-process and receiving quality systems for new processes and components

Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required

Define gages, tools and equipment for the test methods developed

Generate manufacturing instructions for new processes being developed

Work cross-functionally with other departments to accomplish PD task

Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met

Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc

Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data to draw meaningful conclusions

Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes that are being developed

Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize these risks. Also work with PFMEA methodology for risk analysis documentation

Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively. Be able to effectively communicate technical concepts to a variety of audiences, both technical and non-technical, through reports, presentations, and other media

Qualification

Process ValidationProcess DevelopmentDesign of Experiments (DOE)CGxP knowledgeBilingual (English/Spanish)Technical WritingMS Windows proficiencyMicrosoft Office proficiencyRisk AssessmentData IntegrityFactory Acceptance Test (FAT)Site Acceptance Test (SAT)