R&D Engineer

Job description

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 were 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 dont 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 70000 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:
Description

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.
• General
• 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:

• Minimum 4-year Bachelor degree in an engineering or science based field from an accredited college or university.
• Advanced Degree (MS PhD etc.) desirable.
• Lean / Six Sigma Black Belt training preferred.
• 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.

Physical requirements:

• The position requires the ability to…