***OPEN TO LOCAL CANDIDATES IN Bay area, CA CANDIDATES WITHIN THE USA WHO ARE OPEN TO RELOCATING **NO C2C

** Job Details **

Job Title : **Process Development Engineer **

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** Location : Pleasanton, CA (Onsite)

Pay - 70k - 80k/Annum

****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 160 countries.

JOB DESCRIPTION:

Leading an active lifestyle is important to the many people we serve. In client'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 Process Development Engineer at our Pleasanton, CA location. This position will design and develop manufacturing processes in order to meet program milestones for the New Product Introduction (NPI) team in the Heart Failure division.

WHAT YOU’LL DO

• Design and develop manufacturing processes, tooling, and fixtures in order to meet new product program schedules while enhancing productivity and product quality

• Drive process improvements and validations through manufacturing implementation and update pFMEAs and master validation plan as required. Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.

• Understand principles of “Cost of Goods Sold” (COGS) relative to material, direct labor, and overhead costs as well as in consideration to manufacturing process yields.

• Utilize various tools (DMAIC, Gage R&R, Cp, Cpk, SPC, etc.) to analyze & improve processes, components, & products.

• Partner with R&D to ensure adherence to Design for Manufacturability (DFM) principles

• Drive change orders impacting manufacturing process documentation, product structure, product/component specification changes & improvements

• Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.

• Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams

• 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

• Bachelors of Science degree in Mechanical, Biomedical, or Electrical Engineering, or equivalent

• Minimum 2 years of relevant engineering experience

• Demonstrated experience with electronic hardware or software systems

• 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

• Ability to travel up to approximately 10%, including internationally

Preferred

• Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.

• Previous medical device experience

• Experience with running change orders in Windchill product lifecycle management software

• Use of Design of Experiments (DOE) in process optimization

• Cleaning validations

• Cleanroom manufacturing best practices.

*OPEN TO LOCAL CANDIDATES IN PLYMOUTH, MN

****** CANDIDATES WITHIN THE USA WHO ARE OPEN TO RELOCATING**** **NO C2C

** _ Job Details _
**

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Job Title : Continuous Improvement Engineer**

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Location : Plymouth, MN (Onsite)

Pay - 40k - 56k/Annum

Looking for a professional who would like to join the project and make a difference in medical industry.

• Non Exempt
• Years Experience: 2 - 5 years
• Skills: Strong follow ups and execution skills. Strong Change Management & Facilitation skills. Good communication skills
• Education: 2 or 4 year degree

Duties: Primary Job Function / Primary Goals / Objectives:

• Responsible for creating an environment and assisting leadership and customers in the timely and successful implementation of business excellence program at site.
• Act as a change agent to grow culture. Lead and motivate others to action in order to accomplish multiple objectives with a sense of urgency and while continuously engaging staff and promoting a sense of team.
• Identify and facilitate process improvement projects, training/ workshops to drive cultural change
• Conduct root cause analysis to determine metrics, troubleshoot distribution and warehouse issues, material flow, project plans, production capacity, facility design and create process documentation.
• Actively manage & support sustenance of Operational Excellence (OpEx) foundations such as 5S, Visual factory & GMP standards.
• Ensure audit compliance for EHS (Safety meeting compliance / Zero major audit observation/Near Miss / BBS)
• Assist/Support management to ensure all employees are participating in OpEx activities and training programs.

*****OPEN TO LOCAL CANDIDATES IN PLEASANTON, CA OR CANDIDATES WITHIN THE USA WHO ARE OPEN TO RELOCATING **NO C2C

_ Job Details _

Job Title : Continuous Improvement Engineer / Kaizen Facilitator / Project Coordinator **
** Location : Pleasanton, CA (Onsite)

Looking for a professional who would like to join the project and make a difference in medical industry.

*Preferably Consulting experience OR 5-15 years of industry experience (Preferred medical devices OR chemical or manufacturing, etc. just NOT high tech or automation environment)

Main responsibilities:

• Models processes and units operations.
• Identifies and resolves constraining bottle neck operations utilizing Value Stream Mapping.
• Rebalances and configures respective flow cell designs consistent with both current and future state productivity and yield metrics.
• Develops detailed facilities layouts and serves as leader in facilitating their execution.
• 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.

_ Other requirements:_

• Cycle Time Analysis
• Process mapping and working on flowchart experience
• Visual management and change management
• Value stream map
• 10-15 years working experience on continuous improvement in line manufacturing environment (not automated environment)
• Experience within medical devices preferred manufacturing, chemical or engineering.
• Consulting or Corporate experience
• Kaizen facilitator experience.
• Great communication skills
• Working independently with minimal directions

Senior Continuous Improvement Engineer to work closely with the cross functional Value Stream teams. This position will design, develop, standardize and implement Operational Excellence methods intended to continuously improve manufacturing system performance. This individual is an influencer and facilitator, with a track record of managing change. This individual is a systems thinker who solves problems by building relationships and collaborating.

_ Impact this role will have :_

• Participates in identification and planning of department goals and budget, development, standardization and implementation of initiatives intended to improve the quality, cost and delivery performance of Abbott.
• In conjunction with the Value Stream teams, supports productivity, quality, process efficiency, space utilization, standardization and lead time improvement efforts.
• In collaboration with the Continuous Improvement Department, supports Lean, Six Sigma and DMAIC problem solving initiatives.
• Identifies opportunities and drives incorporation of appropriate Lean tool usage such as 5S, time study, line balancing, standard work, material flow and value stream mapping into the daily functions of the Value Stream teams.
• Collaborates with cross functional teams as required.
• Provides input into departmental budgeting processes as required.
• May supervise and provide work direction to other engineers and technicians.
• Understands work environment issues (i.e. OSHA regulations, etc.).
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• 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.
• Performs other related duties and responsibilities, on occasion, as assigned.

_ Experience, education and knowledge:_

• BS in Industrial Engineering or related field or equivalent experience; advanced degree preferred.
• 5+ years manufacturing engineering experience.
• Medical device experience preferred.
• Strong analytical, problem solving and project management skills.
• Demonstrated leadership capability in team settings.
• Six Sigma or Lean Certification preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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.
• Ability to travel approximately 15-30%, including internationally.

DivisionHF Heart Failure

SiteUnited States : Pleasanton, CA