R&D Engineer

Fujifilm•Lexington, MA

About The Position

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.

Requirements

Minimum 4-year Bachelor degree in an engineering or science based field from an accredited college or university.
The candidate will have a minimum of 3 years of experience in product development and manufacturing in the medical device industry.
Experience in mechanical engineering, medical device manufacturing, materials for medical devices and plastic and metal processing and clean room assembly.
Strong problem solving skills.
Knowledge of statistical techniques and analysis.
Strong knowledge of FDA regulations and guidelines, governmental requirement practices (GMP, GCP, GLP, GVP, ISO) and other international clinical, regulatory requirements.
Knowledge of the device development process and contract manufacturer management.
The ability to sit up 75-100% of applicable work time.
The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
The ability to stand, talk, and hear for 75% of applicable work time.
The ability to lift and carry up to ten pounds up to 20% of applicable work time.

Nice To Haves

Advanced Degree (MS, PhD, etc.) desirable.
Lean / Six Sigma Black Belt training preferred.

Responsibilities

Define the design and development plan of R&D projects in accordance with currentregulatory 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.
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.
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.