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Manufacturing Engineering Manager

4 months ago

Ball Ground, United States CAIRE Full time
Job DescriptionJob Description


Company Overview:

CAIRE is a global engineering solutions and medical device company providing leading oxygen related products to the Healthcare and Industrial/Commercial markets. We support customers in over 100 countries and have operating facilities in the US, Germany, UK, Italy, Japan and China.

In 2018 CAIRE joined NGK/NTK, a global industrial spark plug company with a growing healthcare and environmental portfolio of products. CAIRE is a wholly owned subsidiary of NGK/NTK but operates predominately as an independent company with headquarters just north of Atlanta in Ball Ground, Ga. Read more CAIRE news at www.caireinc.com.

Primary Function of Position:

Contribute your technical manufacturing, leadership, and project management skills to a dynamic manufacturing engineering team. Creating. This key technical management role will guide and mentor a talented engineering team responsible for supporting CAIRE, Inc. manufacturing by creating manufacturing processes, authoring all associated manufacturing documentation, dispositioning discrepant material, and maintaining compliance with our quality system.


Roles and Responsibilities:

  • Lead a team of Manufacturing Engineers, in collaboration with other functional groups.
  • Production of complex products with responsibilities including but not limited to:
    • Establish group and individual objectives, priorities, and metrics.
    • Ensure fulfillment of product development goals for CAIRE projects.
    • Ensure the professional development of individual team members.
    • Ensure production of products meets expected output.
    • Ensure quality requirements are fulfilled and maintained.
  • Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.
  • Provide technical support for failure analysis and root cause investigation of product failures.
  • Promote and lead VA/VE ideas and projects.
  • Plan, budget and staff projects, tracking performance throughout.
  • Manage and allocate team resources over multiple projects.
  • Provide and solicit resources to and from other teams as necessary.
  • Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
  • Improve product quality, yields, and reduce cost.
  • Improve the manufacturing process as needed.
  • Complete cost analysis and lead cost reduction efforts.
  • Mentor and train new employees.
  • Create, maintain and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
  • Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
  • Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
  • Provide production line support for day-to-day engineering issues on core equipment.
  • Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
  • Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
  • Other related duties.

Qualifications

Skill/Job Requirements:

  • Minimum B.S. degree in engineering discipline, M.S. preferred.
  • Successful experience leading projects, and juggle multiple business demands
  • Minimum of five years’ engineering experience manufacturing complex electro-mechanical products.
  • Ability to motivate, mentor, and inspire a diverse skillset technical team.
  • Experience developing products from concept to volume manufacturing.
  • Mechanical design and analysis expertise desired.
  • DMAIC and Lean Six Sigma experience, black belt preferred.
  • Prior responsibility for validation of processes, equipment and products.
  • Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk/Cp.
  • Familiarity with mechanical CAD (Solidworks) and MS Project software.
  • Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
  • Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
  • Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments is a plus
  • Ability to work in a Matrix org structure with cross functional Value Streams
  • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
  • Able to travel periodically to suppliers, other Company sites.

Work Environment

This job operates in a professional office as well as medical device production and development environments. This role, as well as all roles, are expected to use standard office equipment, computers, and continually adapting to new technologies and changing work environments. The work environment is primarily located in Pleasanton, CA.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Frequent standing, sitting and walking.
  • Occasional lifting up to 10 lbs.
  • Use of instruments and hand tools.
  • Presence on domestic production and assembly floors.