Principal Engineer

6 days ago

Boston, Massachusetts, United States InnoTECH Staffing Full time

InnoTECH Staffing is looking to hire a Principal Manufacturing Engineer who has Class II or III medical device experience experience.

** This requires being onsite 5 days a week in Boston, MA.

This position is responsible for leading the process engineering and production support for the company's core product line.

You will transition advanced prototypes from R&D to scalable, high-quality production; provide technical leadership and support for continuous improvement team efforts focused on process improvement and optimization; and provide engineering leadership for design for manufacturing, manufacturing bring-up, test development, equipment selection, operation and optimization.

Responsibilities

  • Leads process engineering and production support activities at contract manufacturing partners CMOs.
  • Leads the introduction of new products into manufacturing.
  • Collaborates with R&D and suppliers to improve product robustness and manufacturability both pre- and post-release.
  • Resolves complex production issues at scale, from root cause identification to validated solution deployment.
  • Writes process procedures, change orders, equipment specifications, validation plans, and reports.
  • Performs research on technology, equipment and tooling to improve process quality, yield or cost.
  • Generates proposals for equipment purchase and implementation, including cost of ownership, ROI and benefit analysis.
  • Provides technical guidance and leadership for continuous improvement including process improvements and product manufacturability improvements.
  • Performs engineering design of test equipment, assembly equipment, fixtures and tools; performs IQ/OQ/PQ validation activities
  • Responsible for establishing the Manufacturing Quality Plan (MQP) for a product.
  • Role has no management responsibility, but is expected to provide technical guidance and engineering mentorship to more junior members of the technical team.

Qualifications

  • B.S. in Engineering and 8+ / 11+ years of experience or an advanced degree and 6+ / 9+ years of experience
  • Experience developing Class II or III implantable devices
  • Experience taking multiple products from concept to manufacturing
  • Proficiency with CAD modeling tools (e.g. SolidWorks)
  • Experience integrating PCBs and electronic subassemblies into mechanical designs
  • Experience with manufacturing methods such as injection molding, mold design, fixturing, machining, and laser welding
  • Experience with neural leads and IPG production preferred
  • Experience implementing robust manufacturing processes at the micron-millimeter scale
  • Experience selecting materials for implantable devices (ISO preferred
  • Experience working with and managing contract manufacturing partners a must
  • Excellent organizational, communication and teamwork abilities
  • Strong analytical and problem-solving skills and expertise using structured analytical techniques

This position is full-time based in the Boston office and requires being onsite 5 days a week.

Domestic travel required.

Must be a US Citizen or Permanent Resident - there is no sponsorship available.

$150K to $195K base depending on level and experience plus medical benefits, time off and stock options.

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