Senior / Principal Process Engineer

Senior / Principal Nitinol Process Engineer

Insight Global is seeking a Senior / Principal Nitinol Process Engineer to support Boston Scientific onsite in Arden Hills and Maple Grove, MN. This consultant will play a critical role in supporting a First-in-Human clinical build for a high-visibility electrophysiology product.

The role is highly hands-on and lab-focused, involving heat-set tooling, component iteration, and close collaboration with R&D, project teams, and tooling vendors. The engineer will act as a manufacturability expert, ensuring early design decisions support long-term scalability while delivering clinical components under aggressive timelines. This position is ideal for a senior-level engineer who thrives in early-stage programs and can operate with minimal oversight.

Responsibilities:

Serve as the primary process engineering owner for a fast-moving clinical build program within EP

Lead development and execution of manufacturing processes for Nitinol components supporting FIH readiness

Perform hands-on lab work including:

Heat setting and shape-set tooling setup

Tooling iteration and optimization

Component measurement and evaluation

Partner closely with R&D and design engineering to influence design and specification decisions with manufacturability and future scale in mind

Lead or heavily influence early-phase tooling design, including coordination with internal teams and external vendors

Manage tooling and component iterations to support delivery of 50 components per week / 200 per month

Deliver:

Clinical-ready components

Tooling designs and/or finished tooling

Process documentation supporting clinical manufacturing

Document process parameters, assumptions, and rationale in alignment with regulated development practices

Skills and Requirements

Must Haves:

8+ years of hands-on Nitinol process engineering experience within medical devices

Proven experience supporting early clinical builds

Strong expertise in shape-setting and heat-set tooling, including early-phase tooling iteration

Experience working with laser-cut Nitinol components

Working knowledge of Nitinol post-processing (electropolishing, passivation, etching, oxide control)

Demonstrated ability to influence design teams on manufacturability and specification decisions

Experience operating independently in fast-paced, ambiguous, early-stage programs

Background working in an ISO 13485 regulated environment Nice to Haves:

Ability to physically design tooling (SolidWorks or similar) or strong experience directing tooling design through vendors

Experience managing or heavily collaborating with external tooling and manufacturing vendors

Background in electrophysiology or cardiovascular devices

Experience supporting transition from prototype to scalable manufacturing concepts

Hands-on lab experience with heat-set tooling optimization and iteration