NPI Operations Manager - Med device

San Francisco, CA   |   Full time

[What the role is]

The NPI Operations Manager role is in charge of all manufacturing aspects of bringing the Spire FDA approved product to market. Including: transfer of manufacturing from non ISO to ISO-13485 certified factory, developing frameworks & procedures for managing quality throughout the supply chain, identifying and resolving process issues, and QC documentation.  He or she will manage and execute IQ, OQ, and PQ processes.  This role is key to bringing Spire's supply chain and product into compliance with a regulated environment.  

[What you'll do]  

  • Oversee the timely and effective introduction of Spire’s innovative wearable products to the healthcare market.  This includes conversion from non-regulated to regulated manufacturing and managing milestones to ensure that all testing and pre-production processes are completed prior to the ship date of the first production units. 
  • Work closely with the Engineering teams in the development, verification, manufacturing transfer and validation of new products as needed. 
  • Establish proficient NPI processes at the Contract Manufacturer to ensure timely shipments of new product builds that meet Prototype, Pilot and Production standard. 
  • Qualifies, documents and introduces production and service assembly/test electromechanical fixtures and equipment.   
  • Takes ownership of new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, escalating and resolving manufacturing issues. 
  • Helps to create an efficient mid-volume manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions. 
  • Provide input to various assembly processes, with a keen eye towards automation where appropriate. 
  • Provides product and process DFM (Design for Manufacturing) input to Engineering to enhance manufacturability and servicing. 
  • Responsible for maintaining compliance with medical device quality system requirements including creating product documentation if it doesnt exist, corrective action closure, discrepant material dispositions and ECO implementation. 
  • Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns. 
  • Leads/participates in initiative focused on material cost reduction, capacity enhancement, outsourcing of assemblies, etc.  

[Who You Are]

  • Bachelor's degree in Engineering, bio-medical, or other related field, Masters degree a plus 
  • 5-10 years of experience working in medical device industry 
  • Sound knowledge of manufacturing operations and electrical device engineering, and test development.  Experience with various assembly processes a plus: heat press/RF weld/automated soldering/ dispensing/ laminating etc. 
  • Experience with test infrastructure, and determining critical functional test items, understanding what can/should be bought off the shelf, what should be contracted out, and what should be built internally 
  • Experience working with overseas CMs setting up lines and doing design transfers a plus
  • Must possess strong communication skills to interface with product development, suppliers, regulatory, inspection, customer support and clinical marketing organizations. 
  • Excellent written, verbal and presentation skills 
  • Strong organizational and project management skills 
  • Familiarity with the use of CAD, NX preferrable as well as PLM 
  • Familiarity with stats software like JMP, minitab; bonus if you have written custom scripts in R, python 
  • Startup experience a plus 

[What you’ll get]

  • A chance to contrinute to a company changing the way people think about and improve their health. 
  • Competitive salary and significant equity in a well-funded, high-growth company. 
  • Catered lunches Mon & Fri each week, commuter benefits, 401K 
  • An opportunity to work with a fun, close-knit team and have significant opportunities for growth. 
  • 100% premium coverage for healthcare, dental, and vision insurance for you and your family. 

[Who We Are]

Spire Inc is a startup in the Mission district of San Francisco.  The Spire Health Tag is a revolutionary bio-monitoring device, recently launched online and in Apple retail stores. The Spire platform is transforming healthcare through real-time, continuous health monitoring. The invisible, clinically-accurate sensors and advanced algorithms are being used across a wide range of health applications, from consumer health & wellness to respiratory-related chronic diseases.

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