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Abbott · 7 hours ago

Process Development Engineer II

United States - California - Santa Clara

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

1+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a Process Development Engineer II, you will support manufacturing operations, focusing on quality, output, and yield while collaborating with various teams to address manufacturing line opportunities. This role also involves leading continuous improvement projects and acting as a mentor to less experienced engineers.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Responsible for assigned line output, safety, yield and quality. Responsible for identification of product defects and determination of operational and process related actions to reduce the defects. This may also include equipment trouble-shooting and sub-sequent work order request

Works with line support team (QC supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform on line issue triage to evaluate issues and determine if non-conformance is present, determine initial bracketing and containment, and generate corrective actions/preventative actions as needed

Responsible for product/process knowledge and understanding of basic cause and effect of line changes. Considered and expert in statistics, product and Engineering process

Responsible for modeling/drafting assemblies; fixtures & tools; Solidworks mid to advance level

Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implementation). Knowledgeable of procedures related to equipment controls

Support technicians and supervisors in equipment availability issues

Supports Training and Certification Program. Provides additional insight on how to improve trainings and certifications in the best interest of the business

Responsible for determining quality impact of Out-of-Tolerance documents

Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and CR generation related to moderate to complex changes impacting the manufacturing line

Responsible for continuous improvement projects development and execution, including CAPAs implementations. Responsible for exception subtask execution

Evaluates ideas for continuous improvements

Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s. Leads CAPA (Major) investigations with data gathering and analysis as needed. Owns CAPA activities without oversight

Runs studies and validations on the line as needed

Be the ME representative for manufacturing related projects including yield, CIP's, productivity, quality and safety

Responsible for coordination of product builds through the NPI process

Generates all types of changes to the eLHR system

Leads ME support during external and internal audits

Acts as coach and mentor to more inexperienced engineers or technical personnel

Leads statistical analysis for complex events at the site

Can generate qualification and validation protocols and reports with minimal oversight

Owns basic to medium to high complexity CR activities with no oversight

Demonstrates comprehensive understanding of regulations in area of work and where to look for information. Considered SME for most Engineering matters

In conjunction with RA: Understands regulatory implications of proposed changes. Understands what types of changes require filings. Completes documentation to support regulatory filings with oversight

Minimal oversight required for problems or assignments of reasonable difficulty. Makes decision in an efficient manner, even when having limited information

Considers risk mitigation in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision-making process. Anticipates potential situations that may impact projects timeline and resolves them before they become an issue

Prepares and provides well thought out contribution to meetings. Provides technical guidance to peers that facilitates the progression of the project, group or person

Can present information and collaborates with peers across functions (both internally and externally). Exposure to cross functional mgmt. communications

Leads manufacturing engineering projects of high complexity, including CIPs, CAPA, Validations

May have delegation authority for area manager

Qualification

Manufacturing/Process EngineeringSolidworksStatistical analysisQuality EngineeringRegulatory knowledgeOffice applicationsCommunication skillsInterpersonal skills