Manufacturing Engineering Program Manager

The Manufacturing Engineering Program Manager will work closely with manufacturing partners to ensure they are producing high quality and cost-effective products by driving manufacturing transfer and production activities. This individual will manage the scale-up of new manufacturing lines and oversee daily production for existing products; troubleshoot manufacturing issues, provide engineering and quality input to manufacturing partners. The Manufacturing Engineering Program Manager may be required to perform all or a combination of the following essential responsibilities as determined by necessity. This position will report to the VP, Operations. This role will be located in the Company’s Woburn, MA office.

Essential Responsibilities:

  • Develop, manage, and maintain plans for existing product transfers and new product startups
  • Coordinate manufacturing and production requirements, and lead internal cross-functional project teams across various functional areas to include R&D, Quality, Production Planning, and external customers
  • Oversee manufacturing process development and validation, either in-house or at contract manufacturers
  • Responsible for ongoing demand planning and product supply related to the planning, procurement, manufacturing, and delivery of products from the supplier
  • Oversee manufacturing test planning, development, and execution. Work with R&D to define test requirements, as well as contract manufacturers and external test equipment development partners
  • Planning, approval, and management of all internal manufacturing and process development activities
  • Approval of manufacturing process validation protocols and reports, both internally and at contract manufacturing partners
  • Planning and management of manufacturing and supplier projects and programs

Experience & Training:

  • Minimum of a bachelor’s degree in Engineering, Manufacturing Engineering, or Program Management is required
  • Minimum of 7 years of medical device manufacturing experience required
  • Knowledge of electronics and plastics manufacturing in medical device new product introductions, manufacturing, technical transfers, and supply chain
  • Program management experience in sourcing materials to support product development initiatives, electronics based medical device finished products manufacturing, and assembly-oriented manufacturing environments
  • Experience with ISO 13485 compliant medical device projects and manufacturing environments
  • Working knowledge of Quality System elements including Design Controls, Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), 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 clinical and technical data to the 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 standard Project Management tools such as MS Project/Smartsheets, Excel, Word, etc.
  • Availability to travel up to ~20%, when necessary

Please send your resume to