Hardware Quality Engineer

Date: Sep 23, 2021

Location: Rochester, NY, US

Company: Carestream Health

Carestream Health Inc. 

Innovation that sparks imagination. Continue on to your next challenge with us. 

Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications—all backed by a global service and support network. Carestream’s diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.  

At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact. Join our global team of 4,000+ professionals!

Position Summary:

We are looking for an energetic individual who wants to be part of a growing, entrepreneurial company that is committed to delivering high quality products, services, and solutions that meet radiology customers’ needs. Our employees drive our innovation and success, while enabling them to show their potential, stretch, and growth. Hard work, talent, and proactively demonstrating results are rewarded by career development and advancement opportunities.
The individual will be responsible for test planning and execution on a variety of hardware equipment platforms that shares a common PC application interface. The hardware platforms range from Non-Destructive Testing to Medical Digital Radiography that facilitates the capture of patient radiographic images, assignment of those images to a particular patient, and the delivery of those images to various hardware and software destinations.

Position Responsibilities:

Responsible for supporting new product development/manufacturing and process compliance to regulatory requirements. Responsible for (but not limited to) the following:

Contribute to new product development/manufacturing in areas of verification & validation of product requirements, regulatory requirements, specification development, measurable outcomes, hazard and safety analyses and other quality activities necessary to meet project objectives in the hardware/software/manufacturing arenas.
Creates and executes test plans, including process certification and manufacturing quality plans
Develops schedules/resource plans for the testing portion of a project
Documents and deliver to the appropriate repository all test results, analysis and test summary reports
Represents customer perspective in project quality decisions
Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion.
Supporting Regulatory agency audits and inspections
Testing assignments on updates to existing products
Duties may include leading cross-functional corrective action team(s)
Duties may include activities to support the customer complaint process
Duties may include supplier quality and audit activities

Required Skills & Education:

  • 5+ years of demonstrated engineering skills
  • Bachelor's degree in Engineering (electrical or mechanical), Imaging Science, or the Clinical domain (preferably in engineering for medical devices) or equivalent.
  • Ability to provide direction to and apply statistical tools
  • Demonstrated data-driven decision making
  • Ability to influence within peer group and higher management
  • Excellent attention to detail
  • Leadership skills
  • Strong analytical, decision-making and problem solving skills.
  • Excellent written and verbal communication

Desired Skills:

  • Quality Engineering, manufacturing or service experience within a FDA regulated medical device industry.
  • Competent in the use of statistical software (ex.  Minitabb, Reliasoft, etc)
  • ASQ Certification (CQE, CRE)
  • Six Sigma Black Belt or Green Belt Certification
  • Competent in the use of quality tools (ex. Reliability, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, ANOVA, Cpk, etc)

Work Environment:

Office

Carestream is an Equal Opportunity Employer

Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Applying for a job with Carestream

All Carestream employees must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations

Requisition ID: 1451 


Nearest Major Market: Rochester