Manufacturing Engineer - Medical Device

  • Category
    Engineering
  • Location
    Woburn, Massachusetts
  • Type
    Direct hire

Manufacturing Engineer - well  funded medical device start-up developing solutions to address age related skin issues. 

Come join a small team doing some really big things in aesthetic devices

Greater Boston area
 

Summary:

The Manufacturing Engineer will work closely with manufacturing partners to ensure they are producing high-quality, cost-effective products that meet the Company’s  production needs by directly overseeing production activities at manufacturing sites. This individual will drive weekly meetings with key manufacturing partners ensuring cross-functional and intercompany alignment on all finished product production. This role will also support continuous improvement and cost reduction efforts on existing manufacturing lines as well as supply chain efforts as necessary. The Manufacturing Engineer may be required to perform all or a combination of the following essential responsibilities as determined by necessity. This role will be located in the Company’s Woburn, MA office with regular travel to our contract manufacturers.

 

Essential Duties and Responsibilities:

  • Support all internal and external manufacturing processes.
  • Troubleshoot manufacturing issues, providing engineering and quality input to manufacturing partners.
  • Support manufacturing process development and validation, either in-house or at contract manufacturers with a focus on product quality.
  • Support existing product transfers and new product startups with potential contract manufacturers.
  • Develop processes that support the scale-up of manufacturing capacity.
  • Support test planning, development, and execution.
  • Work with R&D to define test requirements, as well as contract manufacturers and external test equipment development partners.
  • Development of manufacturing process validation protocols and reports, both internally and at contract manufacturing partners.
  • Support R&D to develop high-quality products that are manufacturable, reliable, and sustainable.

 

Education and/or Experience:

  • Minimum of a bachelor’s degree in Mechanical or Manufacturing Engineering.
  • 2- 5 years of medical device manufacturing experience
  • Experience in developing manufacturing processes for electro-mechanical medical devices.
  • Experience in designing and developing manufacturing and testing fixtures.
  • Experience with ISO 13485-compliant medical device projects and manufacturing environments.

 

Other Skills and Abilities:

  • Working knowledge of Lean Manufacturing Principles.
  • Working knowledge of Quality System elements including Design Controls, Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and CAPA.
  • Familiarity with SPC, Experimental Design, and Statistical Sampling techniques.
  • Excellent interpersonal, project management, and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.
  • Strong written and verbal communication and presentation skills.
  • Ability to present and effectively communicate complex technical data to audiences of various backgrounds and knowledge levels.
  • Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities, and multiple deadlines.
  • Working knowledge of statistical software packages such as Minitab, and standard Project Management tools such as MS Project/Smartsheets, Excel, Word, etc.
  • The ability to collaborate with all levels of management in a matrix environment is required.
  • Availability to travel up to ~20%, when necessary.

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