Process Engineer II - VS Neuro/BioPatch/FP

Integra LifeSciences · Facility

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CMCFull-time$42k–$59kCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Process Engineer II will optimize and sustain manufacturing processes for neuroscience devices at this medical device manufacturer. The role involves cross-functional collaboration to drive process improvements, execute validations, and ensure compliance with regulatory standards including FDA GMP and ISO requirements.

What they're looking for

Bachelor's degree in engineering or equivalent with 2-4 years of experience
Experience managing multifunctional teams across EHS, Quality, Process Development, Planning
Minimum 2 years managing validation cycles (FAT, IQ, OQ, PQ, TMV) and engineering documentation
Proven process monitoring and improvement using statistical tools and Lean Six Sigma methodologies
Bilingual proficiency in Spanish and English preferred; strong technical writing skills
Experience with material change validations and CAPA/technical investigation execution
Statistical process control tools experience (SPC, Minitab) and Design of Experiments preferred

What you'll be doing

Collaborate cross-functionally on process challenges, material changes, lifecycle management, and new product introductions
Execute engineering validations (IQ/OQ/PQ/TMV), change orders, and process specifications per regulatory requirements
Conduct statistical analysis and trending of process parameters to improve yields, reduce scrap, and error-proof processes
Drive process, quality, and cost improvements using advanced technologies and Lean Six Sigma tools
Perform technical investigations, non-conformances, FMEA, and CAPA activities; monitor and report KPI metrics

Key requirements

Therapeutic area: Neuroscience

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Date posted4 days ago

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