Manufacturing Engineer

AMF4SR Alfred Mann Foundation

Innovations For Commercialization

Brief description of job duties:

The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to support product development and production efforts for all aspects of implantable medical devices and systems; research, plans and designs for mechanical and electromechanical products and systems; coordinates activities involved in fabrication, operation, application, installation, and repair of same.

 

Main responsibilities:

  • Develops, evaluates, improves, documents and validates manufacturing methods and test methods.
  • Analyzes and plans work force utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
  • Confers with planning and design staff concerning product design and tooling to ensure efficient production methods.
  • Specifies, designs, analyzes, simulates, prototypes, builds, tests, documents and releases to manufacturing parts, processes, procedures, assemblies, materials and equipment.
  • Organizes, plans, tracks, and closes out design issues associated with product performance in development, test, manufacturing, and the field.
  • Designs products such as instruments, controls, machines, and mechanical/electromechanical, thermal, or hydraulic systems using AutoCad, SolidWorks or other similar programs.
  • Plans testing and directs engineering and laboratory personnel in fabrication of test control apparatus and equipment, and development of methods and procedures for testing products or systems and for improvement of manufacturing processes.
  • Coordinates operation, maintenance, and repair activities to obtain optimum utilization of machines and equipment.
  • Designs and modifies products, procedures, and systems to interface machines, hardware, and software and to improve the efficiency and quality of production.
  • Evaluates field installations and recommends design modifications to improve machine or system malfunctions.
  • Researches and analyzes data such as customer/vendor design proposals, specifications, and manuals to determine feasibility of design on application.
  • Prepares and/or reviews manufacturing documentation.
  • Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
  • Estimates production times, staffing requirements, and related costs to provide information for management decisions.
  • Confers with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.
  • Applies statistical methods to estimate future manufacturing requirements and potential.

 

Education and/or Experience

  • Bachelor’s degree (B.S.) from four-year college or university and two (2) or more years related experience; or five (5) or more years related experience and/or training; or equivalent combination of education and experience. Engineering experience in medical device (or highly regulated industry) design and/or manufacturing is preferred.
  • Fluent with Microsoft Office products (Word, Excel, Outlook, Powerpoint, etc)
  • Reading engineering drawings (e.g. SolidWorks®, AutoCAD®, etc.)
  • Understanding and creating Production / process procedures and associated documents
  • Must have excellent written and verbal communication skills
  • Good understanding of CFR 820 and ISO 13485:2016
  • Methodical approach to problem solving
  • Self-motivated organized team player with high ethical standards

To apply for this job email your details to hr@aemf.org