IMI Precision Engineering Manufacturing Engineer in Concord, California

Overview

Support safety first and the goals of continuous improvement of product quality and cost-effectiveness through Lean concepts and best-in-class manufacturing techniques. Plan, design and validate manufacturing (primarily assembly) processes. Determine the proper equipment, tooling, test apparatus, and prepare all process documents, work instructions and route cards for each manufacturing process. Support New Product Development (NPD), Contract Manufacturing projects, and sustain existing products/components. Champion the ISO 9001-13485 Quality Management Systems and Lean Continuous Improvement programs.

Responsibilities

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily (reference Job Levels section for further clarification). The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Evaluate existing and design new processes for safety, consistent product quality and cost effectiveness.Maximize efficiency through Lean concepts: analyzing layout of equipment, workflow, assembly methods, material handling and work force utilization.

  • Create process documentation, including: validations, assembly drawings, work instructions, bill of materials (BOM) and routings. Conduct Process Failure Modes Effect Analysis (pFMEAs) and develop and implement countermeasures to reduce risk (e.g. control plans).

  • Determine, document and validate the proper equipment, tooling, test apparatus and packaging. Includes designing, creating drawings and bills of material.

  • Perform sustaining engineering tasks for released products. Utilize theEngineering Change Order (ECO) process, report writing and/or other appropriate protocolsto document changes.

  • Work with the Operation’s personnel, suppliers and customers to troubleshoot and resolve process, product and component problems.Perform root cause analysis on non-conforming materials and processes, including customer complaints (returned products) and implement corrective action plans per established procedures.

  • Maintain equipment operational by coordinating preventive maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.

  • Review existing and new engineering designs/drawings and recommend changes to provide for improved manufacturability, quality and cost. Assist with cost analysis.

  • Support the release of products to the Operation’s team, including new product development (NPD), contract manufacturing, and design transfers from engineering. Includes working directly with customers (primarily contract manufacturing) to support their requirements.

  • Survey and identify replacement components for reasons of obsolescence or cost reduction. Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation.

ADDITIONAL RESPONSIBILITIES

  • Participate as a member of the Safety Team, Material Review Board (MRB), and Supplier Management Council (SMC) and perform tasks as required.

  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Includes knowledge of regulatory compliance standards (i.e., RoHS, REACH, UL, ISO 9001 and ISO 13485, FDA, etc.).

  • Fabricate tooling and equipment (i.e., use of machine shop equipment) as required.

  • Create, implement, and monitor key performance indicators and metrics, including those associated with Lean programs (i.e., cost savings).

  • Support the development of annual capital plan and participate in selection of new capital equipment.

  • Ability to travel in support of job function (IMI plants, customers, suppliers etc.).

INTERACTIONS

  • Work in a demanding fast paced environment. Reference Job Level section for supervision guidelines.

  • Ability to lead and function in a team environment, while effectively communicating across various levels of the organization, suppliers and customers.

  • Provide hands on support to Operations for troubleshooting and training instruction on manufacturing techniques/procedures.

  • Position relies on the capacity to make decisions and perform the functions of the job using good judgment as to when issues need to be elevated.

  • Effectively prepare and deliver technical reports and presentations to internal and external customers.

  • Motivate and continue to develop staff through on-going communications, direct feedback processes, getting buy-in on set goals and objectives, and recognizing ideas that lead to continuous improvements.

Qualifications

Required Qualifications:

  • S. in Engineering

  • Knowledge of mechanical fundamentals and commonly-used concepts, practices, and mechanical procedures, including the application of American Society Mechanical Engineers, Geometric Dimensioning and Tolerancing (ASME GDT).

  • Experience with ISO 9001 quality management system (QMS).

  • Background in lean methodologies and be able to facilitate kaizen events to implement lean improvements as required throughout the factory.

  • Ability to utilize 3D Solid-Modeling tools, preferably Solidworks.

  • Capacity to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

  • Versatile, flexible, and a willingness to work within changing priorities. Self-directed with the ability to manage workflow, organize and deliver on milestones/tasks for assigned projects. Capable of working under pressure.

  • Must be able to speak, read, write, and understand the primary language used in the workplace: Good technical writing skills are a necessity.

Desired Qualifications:

  • S. in Mechanical Engineering with 2+ years of experience.

  • Experience with ISO 13485 medical device manufacturing.

  • Knowledge of mechanical component assembly processes, including ergonomics.

  • Theoretical and practical understanding of fluidics, solenoids, motors, finite element analysis (FEA) and electromechanical devices a plus.

  • Familiarity with validation protocols and reports (ex.: PQ, PPQ, IQ, EOQ, PCAF, TMV, Gage R&R)

  • Ability to operate machinery to create fixtures, tooling (e.g. lathe, mills, band saws, etc).

  • LabVIEW knowledge to assist with programming of test equipment.

Job ID 2018-31407

# of Openings 2

Job Locations US-CA-Concord

Category Engineering

Platform IMI Precision Engineering