Overview/Risks:
Primarily responsible for technical expertise and support for daily processing operations and process improvement projects in either Jessup and/or Edison facilities. Ensure that safety, quality and yield targets are met. Perform Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) on processing equipment. Work with cross-functional teams to provide solutions to processing issues in the core. Work independently on Corrective and Preventive Action (CAPA) project teams and Nonconformances (NCR�??s) related to processing deviations. Direct and plan engineering projects or studies.
Responsibilities:
- Develop and execute validation protocols (IQ/OQ/PQ) to assess process capability, analyze data using statistics, and generate required compliance documentation.
- Investigate, integrate and evaluate the impact of new process introductions.
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Assess and implement process changes as required by internal or external customer request, in response to processing quality issues, or design changes.
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Participate in process risk analysis activities (FMEA) to support new or existing processes.
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Implement change controls and ensure processing documents/procedures/specifications are complete, accurate, and current.
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Perform investigations and root cause analysis for NCR’s. Implement corrective actions.
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Participate in processing investigations/CAPA/complaint resolutions to identify process improvements.
- Develop and deliver new manufacturing process capabilities as needed including process selection, characterization, and qualification utilizing design of experiments (DOE) methodology.
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Support evaluation of new device designs for manufacturability (DFM/DFA).
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Responsible to answer technical questions from marketing, processing technicians, etc. as requested.
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Responsible to resolve immediate safety concerns on core equipment.
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Responsible to facilitate all aspects of process development from feasibility testing to process automation.
- Develop functional gages and create quality inspection procedures to streamline inspection process.
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Program and troubleshoot processing equipment (e.g. CNC, PLCs, HMIs, mechanical and pneumatic systems).
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Responsible for cost reduction and quality improvement projects.
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Train technicians and facilitate technician training as required.
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Enter clean room periodically to qualify and audit processes.
- Work with R&D to develop and implement new high precision machining processes including build prototypes, design fixtures/tools, and perform process capability studies.
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Provide oral and written project updates to individuals and groups as necessary.
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Responsible to discover, investigate and integrate new technologies into the processing area.
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Responsible to transfer new 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.
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Team member on special projects and perform additional duties as assigned.
Qualifications:
MINIMUM QUALIFICATIONS
Education: Bachelor's Degree
Years of Experience: 3 - 5 years
Other: Minimum 3 years of experience in a manufacturing environment.
Specific Licenses and/or Certifications: Other
Other: N/A
Specialized Knowledge, Technical Skills, and Abilities:
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Critical thinking
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Basic statistics
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Ability to work independently and with a team
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Proficiency in Microsoft Office and Project
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Experience in medical device manufacturing or a GMP environment helpful.
- Customer/vendor interaction and strong communication skills.
PREFERRED QUALIFICATIONS
Education: Bachelor's Degree
Years of Experience: 3 - 7 years
Other: N/A
Specific Licenses and/or Certifications: Other
Other: N/A
Specialized Knowledge, Technical Skills, and Abilities:
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Proficiency in CAD/CAM. Solid modeling preferred.
For Trinity: Experience in cryogenic preservation technologies