SEDAA

*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLEASANTON, CA****NO C2C CANDIDATES*************

Job title -Manufacturing Engineer  

Location -  Santa Clara, CA ( fully onsite)

Pay Rate : 50k/Ann- 80k/Ann 

Job id - Sedaa43019

The Senior Manufacturing Engineer will serve as the primary engineering personnel supporting manufacturing operations including process validation activities. The individual performing this role will have strong collaboration with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line. He/She will be accountable on quality, output and yield of the assigned manufacturing line.  He/She will serve as the engineering management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.  This person may also have a role beyond the line support engineering as a sustaining engineer for the department.  As a Senior Engineer, this person is one of the most experienced and expected to be subject matter expert in the site products and process.

 MAIN RESPONSIBILITIES

• Responsible for owning process validation activities such as validation protocols and technical reports (POQ, PPQ)
• Responsible for authoring, execution and reporting for Inspection Method Validations, and Test Method Validations
• 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.

Experience/Background

Experience Experience Details:

• Minimum 5 years
• Process Validations experience is required.

Basic knowledge of applicable US non-US applicable regulations. Knowledge and proficiency in the application and principles of Manufacturing/Process Engineering.

• Ability to effectively communicate cross-functionally to assist with resolving Quality/Engineering issues.
• Catheter assembly experience is required.
• Excellent written, verbal and interpersonal communication skills
• Ability to interact effectively with all levels of employees.
• Knowledge of common office applications: Word, PowerPoint, Excel.
• Knowledge of statistical analysis.

*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLEASANTON, CA****NO C2C CANDIDATES*************

Job title -Manufacturing Engineer - Labeling and Packaging 

Location -  Pleasanton, CA ( fully onsite)

Pay Rate : 50k/Ann- 80k/Ann 

Job id - Sedaa 

Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 150 countries.

JOB DESCRIPTION:

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced, high caliber Manufacturing Engineer onsite at our Pleasanton, CA location. This position will support labeling and packaging manufacturing processes in order to meet program milestones for the Labeling and Packaging Engineering team in the Heart Failure division.

WHAT YOU’LL DO

• Drive projects related to labeling or packaging initiatives including scheduling and leading cross functional reviews.
• Execute change orders in the Windchill product lifecycle management software impacting manufacturing process documentation, product BOM structure, product/component specification changes & improvements
• Update manufacturing, packaging, and labeling processes to meet production demands while enhancing productivity and product quality.
• Support equipment maintenance and resolve production downtime for label printers and heat-sealing packaging equipment.
• Design and release labeling specifications. Lead label cross functional reviews to gather all pertinent information in compliance with Abbott and recognized regulatory standards.
• Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor's of Science degree in Mechanical, Industrial, or Electrical Engineering, or equivalent
• Minimum 3 years of relevant engineering experience
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail

Preferred:

• Previous experience in label design work, with preference in any of the following labeling design systems: Bartender, enlabel, Integration with SAP ERP systems.
• Design experience in the Adobe Acrobat Create Suite, namely Adobe Illustrator, InDesign, and/or Photoshop.

*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO WORK LOCATION****NO C2C CANDIDATES*************

Job title -Manufacturing Engineer II

Location -  Minnesota : St. Paul ( fully onsite)

Pay Rate : 50k/Ann- 70k/Ann 

Job id - Sedaa42585 

This position is Non-Exempt. Hours over 40 will be paid at Time and a Half.

Description:

• Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. 
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks, tasks that may have multiple inter-coordinating elements. 
• Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
• Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities. 

Education:

Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments. 3-5 years exp

*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO CALIFORNIA****NO C2C CANDIDATES*************

Job title -Manufacturing Engineer II

Location - Sylmar, CA  (Los Angeles - fully onsite)

Pay Rate : 50k/Ann- 70k/Ann 

Job id:  Sedaa 42781

Description:

This position is Non-Exempt. Hours over 40 will be paid at Time and a Half.

• Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks ? tasks that may have multiple inter-coordinating elements.
• Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
• Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
• Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments. 3-5 years exp