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Head of Engineering and Manufacturing

Based in Seattle, WA

Tasso, Inc., is a Seattle, WA startup that is revolutionizing blood collection. Our aim is to simplify the blood testing process with a medical device that allows patients to collect their blood sample at home and mail it directly to the laboratory for analysis. We are currently seeking a VP-level Head of Manufacturing and Engineering to transition our products into production.

A high performing individual will possess a broad range of medical device manufacturing and engineering experience to transition products from engineering to manufacturing, following 21 CFR 820 and ISO 13485 requirements. This position reports to the CEO.

Essential Duties & Responsibilities

  • Lead, manage and mentor engineering and manufacturing teams and related personnel

  • Manage engineering and manufacturing budget

  • Build the supply chain

  • Participate in supplier qualification

  • Negotiate contracts with potential and or approved suppliers

  • Ensure timelines are met and investigate delays

  • Support R&D and Engineering in the transition through the design control process from Concept to Post Market

  • Advise on Design for Manufacturability and third party feedback

  • Integrate internal and external feedback into part design and tolerancing

  • Lead semi-automated process development and contemplate downstream automation for large scale production as needed

  • Participate in the development of next generation devices by providing input from a manufacturing and quality perspective; performing design reviews; participate in the design control process

  • Establish and maintain manufacturing meeting the Quality System requirements

  • Work with our internal development team and coordinate with relevant consultants to integrate the appropriate requirements for a medical device

  • Ensure that Tasso meets 21 CFR 820, ISO 13485 and other applicable regulations and standards

  • Performs the verification and validation processes for manufacturing

  • Develop and implement standard operating procedures

  • Lead manufacturing risk assessments and participate in product risk assessments

  • Lead manufacturing and supplier qualification plans

  • Assure the manufacturing documentation transitioning from Engineering to Manufacturing is accurate, readable to assure quality products

  • As a member of the management team, perform other tasks as required

Job requirements and experience

  • Minimum 10 years of experience relevant to medical device product manufacturing

  • Minimum B.S. in engineering discipline or equivalent 6 years of experience

  • Experience in 21 CFR 820 and ISO 13485 regulatory environment

  • Strong preference for proven vendor auditing and contract execution skills

  • Preference for direct experience on developing automation for high volume manufacturing 

If interested, please submit your CV to careers@tassoinc.com.

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