Director, Medical Device Manufacturing Engineering

Are you a talented manager with extensive medical device engineering experience, open to a significant career opportunity? Expanding, commercial stage company has created a challenging position offering broad responsibility leading engineers in Manufacturing Engineering, Facility Operations, and Field Service. The company has pioneered advanced technologies that treat cardiac abnormalities using complex catheters delivering image guided balloons and laser energy. This a great role for a well-organized, hands-on manufacturing engineering manager with technical breadth and managerial skill. He or she will provide leadership and planning for Sustaining Engineering, Process Development and Improvement, and Facilities. The Director will influence technical direction, process evaluation, and improvement and make personal technical contributions.  This high profile position includes regular interaction with executives in R&D, QA/RA, Finance, and Sales & Marketing.

Duties and Responsibilities:

  • Manage departments and cross functional teams to create, support, and achieve manufacturing engineering and field support initiatives and goals.
  • Work with functional departments to collect and analyze manufacturing process data, and identify and implement continuous improvements and resolve problems.
  • Forecast operating costs of department, develop and manage department budget.
  • Work with VP Operations to identify and justify resource requirements.
  • Identify technologies that may improve operations, and develop recommendations.
  • Collaborate with R&D to support new product introductions and initiatives.
  • Advise management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations.
  • Wok with department leaders to satisfy facility manufacturing and R&D requirements.
  • Manage the Field Service Team in supporting customers, resolving difficult situations, and gathering input from their experience.
  • Ensure that initiatives are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures.
  • Identify and resolve problems in a timely manner; Gather and analyze information.
  • Develop staff, balance team and individual responsibilities with openness to others’ views and interests, set expectations. goals and objectives, and monitor outcomes.

Qualifications:

  • BS in an Engineering discipline; an MS in Engineering or Management is a plus.
  • Seven to 10 years engineering management experience within operations, with a minimum of 3 years in a medical device manufacturing environment building complex products.
  • Understanding of COGS and Manufacturing metrics.
  • Solid knowledge of QSR, ISO 13485, Lean principles. Green Belt or higher is preferred.
  • Ability to organize and present data effectively to all levels of the organization.
  • Intermediate or better software skills including PLM systems and Office products

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