Principal Manufacturing Engineer - Class III implant / neuromodulation

Job Description

Job Description

InnoTECH Staffing is looking to hire a fulltime / permanent Principal Manufacturing Engineer for an exciting Class III medical device company in the Boston area.

This requires being onsite 5 days a week.

We are looking for a Principal Manufacturing Engineer to work in the Boston, MA office. 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.

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 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 developing Class III active implantable devices.

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-10993) 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.