Job Summary

Manufacturing Engineer

  • Location:
    Costa Mesa, California
  • Job reference:
  • Category:
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Position Overview:

Seeking a dynamic and proactive Manufacturing Engineer that will be responsible for the design, development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards. The Manufacturing Integration Engineer will collaborate with the product development team and other support organizations to assist in development and introduction of new products and process technologies to production. Primary focus will be to ensure a robust transition of new products/processes which meet cost, quality, and performance objectives.

Essential Functions:

Design and develop highly capable manufacturing processes for new products. Ensure robust transition from product development thru full rate production ensuring process stabilization.
Identify, develop, and integrate new process technologies/capabilities
Design, develop, and qualify new tooling and equipment
Generate/revise manufacturing plans/work instructions, process specifications and procedures and other supporting NPI documentation. Submit/manage Engineering Change Request through approval.
Develop and sustain FMEA’s and QCP’s for NPI.
Verification/Validation of processes, machines and equipment to meet requirements of Medical Device Regulations and Company procedures. IQ/OQ/PQ protocols.
Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans
Create and sustain SAP routings and standards
Support Lean/Six Sigma program to improve product yields, costs, and lead times. Create statement of work (SOW) and equipment specifications. Perform cost benefit analysis (CBA) and justification for new CAPEX equipment.
Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems

Required Qualifications:

Bachelor’s degree from an accredited college in engineering or related science discipline, preferably Manufacturing, Process, Materials, Mechanical, or Mechatronics Engineering, or applied Physics
4 or more years of experience developing and implementing innovative new processing technologies, tool and equipment designs, and machines to enable high yielding product and statistically controlled processes
Strong process development, DOE, and statistical data analysis experience
Direct experience with generating/sustaining FMEA’s and QCP’s
Experience in design and qualification of machines, equipment, and tooling. Demonstrated ability to write and execute IQ/OQ/PQ protocols and reports
Experience with generating/revising manufacturing plans/work instructions, process specifications and procedures, training plans, and applying lessons learned
Must have strong technical, analytical, and extensive problem solving skills
Demonstrated experience with project and/or program management skills
Excellent written and verbal communication skills
Must be proficient in using software including: MS Office, SAP, Siemens NX and/or SolidWorks, and Minitab (or equivalents)
Must be willing to travel to domestic/international locations to support product/process transfers. Anticipated travel is less than 5%.

Preferred Qualifications:

Direct experience and in-depth understanding of laser ablation equipment, materials, and micro processing applications (various)
Experience in micro-termination equipment, such as HBR and ACF bonding, conductive solder/epoxy micro-dispensing and reflow
Direct application experience in equipment and process automation. Automation design, fabrication, and programming background a plus
Working knowledge of insert/injection molding and cable assembly manufacturing processes
Experience with Lean/Six Sigma methodologies and tool sets
Medical Device experience and familiarization with ISO 13485, FDA 21, Medical Device Directives, and all other applicable industry standards in a highly regulated industry
Fluent in latest GD&T, ASME standards

Skills and Abilities:

Strong communication skills both written and verbal necessary for professional interactions with both external and internal contacts.
Interpersonal skills to work effectively with co-workers and external contacts to respond positively to situations, which require cooperation, courtesy and tact.
Detail oriented
Ability to analyze issues and resolve them appropriately
Ability to multi-task and meet deadlines

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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