Process Engineer OR Continuous Improvement Eng. OR Kaizen Facilitator

SEDAA • Pleasanton, CA

16d • $70,000 - $80,000 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level