Sr Director of Operations, Medical Device

Woburn, Massachusetts | Operations Management

Sr. Director of Operations

 

Our client is a Med Device start-up with a product that is so far outside of the “me too” category that they’re on the other side of the Big Green Wall. So, now that you know what part of the country they are in, you also know that the I-90 corridor is a hub for start-ups and a place you want to be.

 

This is a critical, senior role that requires you to have experience in a start-up environment and while it need not be where you are today, it needs to be more than a distant memory. You need to have the kind of savvy to be taken seriously by the Investors and the BOD, but also have a hands-on skill-set that makes you want to be involved up and down the org chart. The project is beyond concept which is why you are needed. From commercialization, to relocating manufacturing (if needed), to ERP implementation; your signature will be all over the end result. 

 

Bring your leadership, your management skills and your willingness to do what it takes during this critical stage of the start-up. (Do you remember packing boxes on the dock?) And while we understand that you don’t get to this level of success without demonstrable skills, how you constrain the presentation of them will be critical to your success.

 

RESPONSIBILITIES:

  • As the Sr. level Ops leader, you will provide hands-on oversight and execution for operations’ targets and milestones as well as responsible to ensure resources are utilized appropriately to meet those
  • Optimizes safety in the production area and warrants Regulatory Compliance
  • Monitors and reports performance against clear objectives including Quality, Safety, Delivery and Personnel; as and where needed
  • Mitigates risk while escalating awareness to the appropriate level
  • Using tools like Process Maps, Risk Assessment (e.g. FMEA), Batch Records, SOP’s, Change Control and Process Validation; is responsible for the transfer of process to internal and external production
  • Champions Continuous Improvement for efficiency, waste minimization and COGS reduction
  • Creates, maintains and reports KPI’s for all manufacturing activities
  • Identifies and manages external contractors, Development & Manuf., working with Quality to identify appropriate measurements and needed results to ensure product quality and safety
  • Leads effective product transfer from Development to Manufacturing
  • Support requests from RA for regulatory submissions and filings
  • Responsible for MRB and participates in CAPA/NCR/Complaint Handling processes
  • Accountable for Supplier/Supply Chain

REQUIREMENTS:

  • A minimum of a BSME or a related discipline; Master’s degree is preferred
  • 15+ years of experience in a medical device company and demonstrable experience in design control
  • Comprehensive knowledge of Catheter manufacturing and its processes; combination product manufacturing experience a plus
  • Readily discernible leadership skills in Project Management, Presentation, Communications and Team Development
  • In-depth understanding of quality systems and design control
  • Working knowledge of a cleanroom environment/management
  • Hands-on understanding of extrusion theory and practice is a plus
  • A willingness to work in a laboratory environment
  • Mechanical skills, including the ability to manipulate common hand tools
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