R&D Engineer

Lexington, KY - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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.

Company Overview

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 perform the following physical demands and/or have the listed capabilities:
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.
Close Vision: The ability to see clearly at twenty inches or less.

Travel:

Occasional (up to 25%) travel may be required based on business need.

In the event that COVID-19 vaccine mandates issued by the federal government or by state or local government become effective and enforceable the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19 absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities including complying with vaccine requirements.

For all positions the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or ).

Required Experience:

Position OverviewThis 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 w...