Principal NPI Manufacturing Process Engineer

7 days ago

Boston, Massachusetts, United States InnoTECH Staffing Full time $150,000 - $195,000 per year

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

** This requires being onsite 5 days a week.

** There is no sponsorship for this role.

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 III active implantable devices a huge plus.
  • 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.
  • 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.

  • Senior Manager, Manufacturing Engineering

    5 days ago

    Boston, Massachusetts, United States Bevi Full time $200,000 - $250,000 per year

    Bevi is on a mission to transform how beverages are delivered and consumed. Our smart hydration systems eliminate the need for single-use bottles and cans—making it easy, fun, and sustainable to stay hydrated. As the category leader in IOT-enabled beverage technology, we're building a future where Bevi machines are everywhere people live, work, and...

  • Senior Manufacturing Quality Engineer

    5 days ago

    Boston, Massachusetts, United States Formlabs Full time $100,000 - $150,000 per year

    About Formlabs:To reinvent an industry, you have to build the best team. Join Formlabs if you want to join us in our mission to build the tools that make it possible for anyone to bring their ideas to life. Formlabs is looking for highly motivated individuals to join us as we bring groundbreaking professional 3D printers to every designer, engineer, factory...

  • Principal Optical Engineer

    6 days ago

    Boston, Massachusetts, United States CT19 Full time $120,000 - $180,000 per year

    Principal Optical EngineerBoston, MA, USAOverviewA leadingneutral atom quantum computing companyis seeking aPrincipal Optical Engineerto join itsHardware Engineering Group. This team plays a pivotal role in advancing the company's mission to buildstate-of-the-art, manufacturable, and deployable neutral atom quantum computers, translating scientific...

  • Principal Engineer,

    6 days ago

    Boston, Massachusetts, United States Amazon Full time $180,100 - $311,200 per year

    DescriptionAt Amazon, Principal Engineers are both visionary leaders and hands-on builders. As Amazon's most senior individual contributors, Principal Engineers work on our hardest problems, help establish technical standards and drive the overall technical architecture, engineering practices, and engineering methodologies for products that delight our...

  • Quality Engineer

    4 days ago

    Boston, Massachusetts, United States Staftonic LLC Full time $80,000 - $120,000 per year

    Position Title:Quality EngineerLocation:Boston, MassachusettsDuration:Long-Term ProjectKey Responsibilities:Design Assurance & Risk Management:Lead design assurance activities for new and existing medical devices, including risk management per ISO Participate in design reviews to ensure product safety, reliability, and compliance with internal and regulatory...

  • Senior Manufacturing Engineer

    6 days ago

    Boston, Massachusetts, United States Whoop Full time $130,000 - $185,000 per year

    At WHOOP, we're on a mission to unlock human performance and healthspan. WHOOP empowers users to perform at a higher level through a deeper understanding of their bodies and daily lives. As a Senior Manufacturing Engineer, PCBA/SMT, you will work cross-functionally with Electrical, Firmware, Mechanical, and Factory teams to develop PCB/A designs and...

  • Principal RFIC Engineer

    2 hours ago

    Boston, Massachusetts, United States Anduril Industries Full time $220,000 - $292,000

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduril is changing how military systems are designed, built and sold. Anduril's...

  • Principal AI Engineer

    6 days ago

    Boston, Massachusetts, United States Hasbro Full time $163,040 - $244,000 per year

    At Hasbro, our mission is to entertain and connect generations of fans through the wonder of storytelling and exhilaration of play. We're looking for adventurous and curious people who want to explore, experiment, and innovate to come up with the best ideas. Our culture has inspired our diverse team of highly skilled, highly creative, and highly committed...

  • Principal Quality Development Engineer

    6 days ago

    Boston, Massachusetts, United States InterSystems Full time $125,000 - $175,000 per year

    The InterSystems IRIS Data Platform is the foundation for industry-leading applications with demanding scalability, resilience, and high availability requirements. Quality Development helps deliver on that promise by subjecting the product to intense scrutiny and extreme workloads.The Systems group is looking for a self-motivated software engineer in test...

  • Principal Transportation Engineer

    5 days ago

    Boston, Massachusetts, United States SLR Consulting Full time $140,000 - $170,000 per year

    At SLR, we don't just design transportation systems – we create sustainable, forward-thinking solutions that connect communities while protecting the environment. We are seeking aPrincipal-level Transportation Engineerto take charge, push boundaries, and help shape the future of transportation nationwide.You'll spearhead major infrastructure projects,...