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Mechanical Manufacturing Engineer (Medical Device Design Services/EMS)

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  • ID: 509439
  • Posted: 6/1/2022
  • Location: Milpitas, CA
  • Category: Pro - Engineering
  • Job Type: Direct Placement
  • Duration: Direct Placement

Description

Acara Solutions is helping our international life sciences design services and PCBA client find a Manufacturing Engineer (with a mechanical background) to join their team at the Milpitas, CA location. This is a direct hire, salaried opportunity. 

Ideal candidates will have a background in the life sciences or medical device industry, manufacturing experience, and mechanical design exposure.

  • In-depth knowledge of mechanical design and integration that enables the ability to evaluate, assess and provide creative solutions to improve the manufacturing process.
  • Working knowledge of fluidic design and layout.
  • Generate and update Manufacturing Work Instructions and Standard Operating Procedures (SOP's).
  • Evaluate and perform first level failure analysis on mechanical parts and assemblies.
  • Provide Design for Manufacturing and Design for Cost analysis as part of New Product Introduction(s) requirements.
  • Champion and drive process improvement and risk reduction by using Process and Design Failure Mode and Effects Analysis (xFMEA's).
  • Initiate and drive manufacturing Cycle Time reduction initiatives: reduce and eliminate Bottlenecks.
  • Demonstrated ability to optimize process flows using Value Stream analysis: drive to theoretical Cycle Time.
  • Develops, plans, directs, and coordinates medical instrument assembly manufacturing processes in production environment. Develops, evaluates, and improves manufacturing methods utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
  • Demonstrated ability to implement Lean 6-Sigma and 5S principles to optimize production cells.
  • Collaborate with suppliers to define and document material and piece/part specifications that will achieve or exceed Customer's performance requirements.
  • Applies statistical methods to reduce process variation. Drive real-time improvements.
  • Initiate, review and approve ECOs, Box-build process instructions, generate new and change manage BOM's. Communicates with internal and external customers to effectively implementation the change in Manufacturing
  • Develops labeling, serialization, packaging procedures for products per ISO and FDA standards as required.
  • Quickly responds to assembly process related manufacturing defects. Implement containment corrective actions quickly followed up with long term solutions. Working knowledge using 8-D's, 5-Why's and Ishikawa diagrams to solve problems.
  • Works well with customer engineers during production line set ups, line tours, process demonstrations.
 
Job Requirements

 
REQUIRED SKILLS/QUALIFICATIONS:
  • Bachelor's Degree in Mechanical Engineering or related engineering/technical field 
  • Minimum of 5 years of experience as a Manufacturing Engineer that includes experience with electro/mechanical system and fixture tool designs
  • Min 2 years of LEAN Manufacturing experience (ideally Six Sigma training or cert)
  • Minimum of 2 years of experience working in a contract manufacturing or electronics organization (or both EMS and electronics)
  • Minimum of 2 years of experience working in the medical instrumentation industry (working knowledge of US FDA 21 CFR)
  • Min 2 years of experience with electro-mechanical systems and fixture tool designs
  • Minimum of 2 years of experience using AutoCAD and/or Solidworks

PREFERRED SKILLS/QUALIFICATIONS:
  • Degree in Material Science 
  • Experience with ISO 9001 and ISO 13485
  • Experience with PCBs/PCBAs
  • Knowledge of reading and creating assembly drawings and stack up tolerance calculation on a system level.
  • Demonstrated expertise using GD&T principles.
  • Experience in working with operators and line supervisors to drive productivity improvements
  • Familiar with general packaging requirements for industrial products.
  • ISO 9001 and ISO 13485 experience preferred

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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