140 applicants

Company

Original Job Post

Balt · 1 week ago

Principal Process Development Engineer

Irvine, CA

Full-time

Onsite

Senior Level

7+ years exp

Wonder how qualified you are to the job?

Health CareManufacturing

H1B Sponsorship

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Responsibilities

Daily work includes both sustaining and project work, focusing on improving safety, quality, output, and eliminating scrap.

Provide support to Manufacturing organization to optimize processes and ensure production goals are met.

Monitor equipment performance, correct process parameters, and integrate new products or processes.

Conduct process validation, knowledge of FDA regulations, and statistical methods.

Develop and improve manufacturing processes, perform analysis, and lead project teams.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

OperationsNPI EngineeringR&D EngineeringClass IIIIIb Implantable Medical Device ExperienceProcess ValidationMedical DevicePharmaceuticalLine LayoutsEquipment QualificationStatistical AnalysisNeurovascular experienceMetalsPlasticsExtrusionAdhesivesSolidworksNicelabelStatgraphicsMicrosoft projectMicrosoft visioMicrosoft accessProblem-solvingPlanning

Required

Four-year degree required, preferably in Engineering.

Minimum 7 years of experiences in position of increasing responsibility in Operations, NPI Engineering, or R&D Engineering

Class III, IIb Implantable Medical Device Experience

Typical experience required is 6+ years as an Engineer in a related field.

Deep process validation knowledge and medical device or pharmaceutical experience is required.

Line Layouts

Equipment Qualification

Statistical analysis skill set is required

Preferred

Neurovascular experience is a plus

Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.

SolidWorks, Nicelabel, and Statgraphics proficiency are highly desired.

Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.

A demonstrated ability to plan and run projects is highly desired.

Company

Balt

The specialist manufacturer of 'Interventional Neuro Radiology’ (‘INR’) devices used to treat strokes and aneurysms

Founded in 1977

Montmorency, Ile-de-France, FRA

501-1,000 employees

http://www.balt.fr/

H1B Sponsorship

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