Operations NPI Manager

HISTOSONICS INC•Madison, WI

8h•$135,000 - $170,000•Onsite

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. We are seeking an experienced Operations NPI Manager to own the end-to-end process of transitioning new products from engineering/design into full-scale manufacturing and operations. This role sits at the intersection of Engineering, Supply Chain, Quality, and Manufacturing, ensuring new products launch on time and meet operational readiness requirements. The Operations NPI Manager leads moderate to highly complex operations projects with minimal direction, working cross-functionally and globally to drive successful product introductions.

Requirements

Bachelor's degree in Engineering, Operations, Supply Chain, or related field.
8+ years of experience in operations, manufacturing engineering, or program management, with significant time in NPI or new product launch environments.
Experience in medical devices.
Experience building NPI processes from the ground up.
Proven track record leading complex, cross-functional product launches from prototype to volume production.
Strong understanding of manufacturing processes, DFM/DFx principles, and supply chain fundamentals.
Experience with stage-gate or similar product development processes.
Excellent program management skills.
Strong communication skills, comfortable presenting to senior leadership and cross-functional, global teams.
Experience with ERP/PLM systems (e.g., SAP, Oracle, Agile, Windchill).

Nice To Haves

Six Sigma / Lean Manufacturing certification.

Responsibilities

Lead multiple moderate to highly complex operations projects for NPD, process improvement, and manufacturing support; provide project management and technical problem-solving support on high-complexity projects as needed; consistently visualize the entire scope of a project.
Partner with cross-functional New Product Introduction (NPI) programs from concept through mass production, serving as the operations owner throughout the product lifecycle.
Partner with Product Development/Engineering teams during design phases to influence design-for-manufacturability (DFM) and design-for-cost (DFC). Track project schedules to ensure adherence to timelines, keeping the operations team and management informed of issues; identify and mitigate project risks, implement risk-reduction plans, and escalate as appropriate.
Coordinate with Supply Chain and Procurement to communicate potential new suppliers and manage components/material readiness — confirming new suppliers have been qualified, parts/components are on order, and operations processes have been created and updated as needed.
Work cross-functionally and globally with Quality & Reliability, Engineering, Sourcing, Finance, Supply and Demand, Marketing, and other departments.
Lead operational readiness and implementation; accountable for operational elements of project execution, including integration of equipment and tooling, capability reviews, manufacturing process, and safety, regulatory, and standards compliance.
Interact with operations, quality, and suppliers to develop processes capable of meeting part/product specifications and performance requirements.
Establish and track key NPI metrics, including on-time launch.
Lead post-launch reviews and drive continuous improvement into future programs.
Communicate program status, risks, and decisions to the Operations organization.