R&D Engineer

Position Overview

This position is intended to report to the Senior Manager, R&D, and working under their supervision, the R&D Engineer supports New Product Development projects. This role develops R&D plans and budgets, and ensures that approved plans are executed on time, within quality guidelines, and within budget. The R&D Engineer provides input on quality, product and manufacturing strategies and is considered a key contributor on all aspects of product development and manufacturing operations.

The R&D Engineer conducts medical device development and manufacturing transfer of projects under their responsibility, in close collaboration with marketing, Quality and Regulatory team members and/or Affiliates and contract manufacturer employees involved in the projects. This role provides guidance on product design, especially design for manufacturing and testing. Furthermore, it takes a leadership role, ensuring the development meets the product requirements, is developed in compliance within quality and regulatory guidance and transfers to manufacturing successfully.

At FUJIFILM Healthcare Americas Corporation, we’re on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics.

But we don’t stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly.

Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive.

Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

Duties and Responsibilities:

Advancement via hands‑on execution of R&D projects:

• Define the design and development plan of R&D projects in accordance with current regulatory and Quality Assurance (i.e., Design Control) guidelines.
• In collaboration with the contract manufacturing, R&D, and marketing teams, contributes to the implementation of the product development plan of R&D projects.
• Execute New Product Development projects in close collaboration with contract manufacturing team to ensure product launch on time & budget.
• Deliver a robust product design following Design for Six-Sigma (DFSS) and Lean Product Development principles.
• Translates customer and product requirements into documentation, methods, and approaches to ensure they are successfully met during product launch.
• Provide design for manufacturing analysis and solutions to improve product designs and manufacturing processes.
• Ensure that manufacturing processes are effectively validated as appropriate.
• Implement appropriate levels of process controls both internally and at 1st and 2nd tier suppliers to support the quality goals of the organization.
• Provide support to the Regulatory, Quality, and/or Clinical functions.

Sustaining Engineering and on‑going support of production processes

• Supports the investigation and analysis of product non‑conformities.
• Main point of contact for manufacturing organization (internal or external), including product performance, testing, process controls and implementation of solutions to production issues for assigned projects.

Meetings and reports:

• Participates in engineering and quality related team meetings and leadership meetings.
• Provide weekly update on the status of the new product introduction projects and transfers to manufacturing.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications:

• Minim…