Primarily responsible for process improvement projects and daily processing support, for Tissue Platform Teams in both Jessup and Edison facilities.
Responsible to develop short-term and long-term solutions to daily breakdowns that cannot be resolved by the Engineering Services group, NCRs, and customer complaint trends.
Responsible to answer technical questions from marketing, processing technicians, etc. as requested.
Responsible to resolve immediate safety concerns on core equipment.
Responsible to facilitate all aspects of process development from feasibility testing to process automation.
Develop and execute process validation protocols, analysis of data and generate required compliance documentation.
Develop functional gages and create quality inspection procedures to streamline inspection process.
Responsible for cost reduction and quality improvement projects.
Train technicians and facilitate technician training as required.
Enter clean room periodically to qualify and audit processes.
Provide oral and written project updates to individuals and groups as necessary.
Responsible to discover, investigate and integrate new technologies into the processing area.
Responsible to transfer new precision grafts and devices into manufacturing. Utilize project management and planning techniques to lead a team through seamless transition from R&D or Project Engineer to Processing.
Team member on special projects and perform additional duties as assigned.
BS degree in mechanical/manufacturing engineering or equivalent..
Minimum Two years experience in a manufacturing environment.
Experience in medical device manufacturing or a GMP environment helpful.
Proficiency in Microsoft Office and Project.
Customer/Vendor interaction and strong communication skills.
Equal Employment Employer – Vet/Disability