Job Description

Job Code: #10276
Title: Manufacturing Eng. (AxioMed)
Date Posted: 07/23/2018
Job Location: Malden MA

Job Description:

  1. Position Overview : Manufacturing Engineer

Responsible for our growing medical device Original Equipment Manufacturer (OEM) business unit. Will be responsible for servicing internal customers (engineering, quality and supply chain) by identifying their needs for engineering support for manufacturing, selection of material, equipment and process for manufacturing viability, process validations, and associated problem-solving duties.

  1. General Responsibilities

  • Develop and implement strategic subcontract management efforts while collaborating and coordinate with engineering and product development teams
  • Collaborate with manufacturers to improve product designs for better manufacturability by coordinating Design for Manufacturability (DFM) discussion
  • Act as a liaison between engineering & vendor as well as quality & vendor from beginning to end of a product manufacturing cycle to facilitate engineering and quality support.
  • Supports development of engineering and quality related solutions to technical and programmatic problems
  • Coordinate and support strategy initiatives to increase supply chain efficiencies
  • Modify 3D models for manufacturing, tolerances, and assembly in conjunction with educating the engineering team
  • Collaborate with engineering design team and quality to release drawings for production
  • Cultivate supplier relationships through on-site meetings and project support
  • Supplier liaison for DFM, Process Validation, product quality and deviation discussions
  • Review and approve ECO’s for inventory part drawings for manufacturability and process
  • Smoothly transition new product development with capable processes into manufacturing with our suppliers
  • Interface with suppliers for rapid prototyping, manufacturing of instruments and implants and testing
  • Participate in the design review process as the Supply Chain representative
  • Assist in the development of internal verification and validation protocols, tests and reports, as required
  • Document data and procedures per AxioMed Quality Management System
  • Participate in the development and execution of internal procedures
  • Develop and manage vendor performance metrics
  • Train internal engineers on DFM best practices, communicate manufacturing technologies and feasibilities
  • Create and update CAD and CAD drawings
  • Assist in supplier qualification and selection process
  • Other duties as assigned
  1. Specific Responsibilities

  • Develop and implement strategic subcontract management efforts while collaborating and coordinate with engineering and product development teams
  • Collaborate with manufacturers to improve product designs for better manufacturability by coordinating Design for Manufacturability (DFM) discussion
  • Act as a liaison between engineering & vendor as well as quality & vendor from beginning to end of a product manufacturing cycle to facilitate engineering and quality support.
  • Supports development of engineering and quality related solutions to technical and programmatic problems
  • Coordinate and support strategy initiatives to increase supply chain efficiencies
  • Modify 3D models for manufacturing, tolerances, and assembly in conjunction with educating the engineering team
  • Collaborate with engineering design team and quality to release drawings for production
  • Cultivate supplier relationships through on-site meetings and project support
  • Supplier liaison for DFM, Process Validation, product quality and deviation discussions
  • Review and approve ECO’s for inventory part drawings for manufacturability and process
  • Smoothly transition new product development with capable processes into manufacturing with our suppliers
  • Interface with suppliers for rapid prototyping, manufacturing of instruments and implants and testing
  • Participate in the design review process as the Supply Chain representative
  • Assist in the development of internal verification and validation protocols, tests and reports, as required
  • Document data and procedures per AxioMed Quality Management System
  • Participate in the development and execution of internal procedures
  • Develop and manage vendor performance metrics
  • Train internal engineers on DFM best practices, communicate manufacturing technologies and feasibilities
  • Create and update CAD and CAD drawings
  • Assist in supplier qualification and selection process
  1. Position Requirements

The successful candidate will be required to possess:

  • An applied and theoretical understanding of engineering and machine shop operations
  • A strong understanding of manufacturing processes
  • Experience in secondary assembly and packaging operations
  • Proficiency in CAD software (SolidWorks)
  • Experience with medical device products
  • Knowledge of medical industry regulation, risk management and design controls (ISO 9001, ISO 13485, ISO 178025, FDA, CFR, etc.)
  • Prior manufacturing process improvement accomplishments
  • Knowledge of GD&T and drafting practices
  • Bachelor’s or Associate’s degree in Mechanical, Mechanical Technology, Manufacturing or Biomedical Engineering

  1. Physical Requirements

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, customer testing specifications, and procedure manuals.
  • Must be able to read, write and communicate fluently in English.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of organization
  • Ability to solve problems and deal with a variety of concreate variables in situations. Ability to interpret a variety of instructions, data and details furnished in written, oral, diagram or schedule form.
  • Lifting requirements: lifting <50 lbs often
  • Ability to stand on feet for long periods of time when in manufacturing
  • Work is performed mainly indoors
  • Work is generally performed within an office environment with standard office equipment available, but will also be working in a manufacturing environment.
  • Travel up to 25%


Application Instructions

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