Process Engineer

2 months ago

Santa Ana, United States OurStaff, LLC Full time

We areseeking a sed temptohire Process Engineer to join a dynamic biotechindustry team. The Process Engineer will lead multiple aspects ofmanufacturing equipment and process design and validation. TheProcess Engineer will work closely with a cross functional teamwhile maintaining equipment uptime and improving upon product costquality andsafety.

EssentialDuties andResponsibilities

  • Responsiblefor developing manufacturing and embly processes consistent withDesign for Manufacturability for new productintroductions.
  • Designsexecutes and doents process validation protocols in support ofquality and regulatoryrequirements.
  • Providesondemand pilot line support managing manufacturing metrics (yieldscycle times capacity bottlenecks) ensuring adherence to quality andcompliance procedures identifying and implementing continuousprocess improvements deploying new fixture and tooling andsupporting manufacturing doentationupdates.
  • Identifiesand develops the crucial equipment related to new productdevelopment and maintains appropriate uptime for currentequipment.
  • istspilot line technicians and engineers on manufacturing problems.Purchases and designs equipment that meets safety and environmentalrequirements.
  • Responsiblefor communicating business related issues or opportunities to nextmanagementlevel
  • Responsiblefor ensuring personnel and Company compliance with all FederalState local and Company regulations policies andprocedures.
  • Leador support troubleing activities and process improvements. Performroot cause ysis of failures. Work on special projects as requestedbymanagement.
  • istwith other responsibilities and/or projects as the need arises.


Requirements

  • Bachelors degree in Mechanical Engineering Biomedical Engineering orrelated field isrequired
  • Minimumof 2 years of industry process engineer experience isrequired
  • Experiencewith commercial or pilot manufacturing lines technical reportwriting statistical ysis and data evaluation isrequired.
  • Knowledgeof good manufacturing practices and doentation isrequired
  • StrongProject Management experience and ss arepreferred.
  • Theability to influence others to achieve businessobjectives.
  • Excellentwritten and oral communication ss isrequired.
  • Knowledgeof production processes standard costs and work standards highlypreferred
  • Ensurepersonal and company compliance with all Federal State local andCompany regulations policies andprocedures.
  • Experiencein a regulated industry is required; medical device experience is aplus.
  • Abilityto travel up to 10% international and domestic isrequired.


Desiredss andtraits

  • AttentiontoDetail
  • Communication(written andverbal)
  • ComputerProficiency
  • Leadership
  • MicrosoftSuite (Excel Word OutlookPP)
  • Seasonedexperience in multiple facets of manufacturingoperations
  • Experiencein Lean/SixSigma.
  • Handsonleader who understands employee engagement is a strong team buildercoach and Understands the importance of culture and being true tothe core values of theorganization




BenefitsCompanyprovided lunch to all employees when working at the worksite.

Responsible for developing manufacturing and embly processesconsistent with Design for Manufacturability for new productintroductions. Designs, executes and doents process validationprotocols in support of quality and regulatory requirements.Provides on-demand pilot line support, managing manufacturingmetrics (yields, cycle times, capacity, bottlenecks), ensuringadherence to quality and compliance procedures, identifying andimplementing continuous process improvements, deploying new fixtureand tooling, and supporting manufacturing doentation updates.Identifies and develops the crucial equipment related to newproduct development and maintains appropriate uptime for currentequipment. ists pilot line technicians and engineers onmanufacturing problems. Purchases and designs equipment that meetssafety and environmental requirements. Responsible forcommunicating business related issues or opportunities to nextmanagement level Responsible for ensuring personnel and Companycompliance with all Federal, State, local and Company regulations,policies, and procedures. Lead or support troubleing activities andprocess improvements. Perform root cause ysis of failures. Work onspecial projects as requested by management. ist with otherresponsibilities and/or projects as the need arise

Education

Bachelors degree in Mechanical Engineering, Biomedical Engineering orrelated field is required

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