Cantel Medical

Principal Design QA Engineer

US-MN-Plymouth
Job ID
2017-3651
# Positions
1
Category
Quality / Regulatory
Cantel ENDO

Company Overview

CANTEL MEDICAL IS A LEADING PROVIDER OF INFECTION PREVENTION PRODUCTS AND SERVICES IN THE HEALTHCARE MARKET, SPECIALIZING IN THE FOLLOWING OPERATING UNITS:

ENDOSCOPY

Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. This segment is operated through MEDIVATORS.

WATER PURIFICATION AND FILTRATION

Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc.  and MEDIVATORS.

HEALTHCARE DISPOSABLES

Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc.

Job Overview

The Principal Design Quality Assurance Engineer leads efforts to support Cantel Medical’s Product Development and Sustaining Engineering teams by playing a key role in Cantel’s Product Development and Design Control processes. Product Design QA Engineers are responsible for engineering activities, including review and gap assessment of design requirements, development, execution and maintenance of risk management plans and activities, identification of applicable standards, review of component and system level specifications, test method development, test plan and protocol development for Design Verification and Design Validation activities, data review and analysis from key testing activities, participating in Design Stage Reviews and process validation activities related to Design Transfer to Manufacturing. Cantel’s Principal Design Quality Assurance Engineer will be the senior leader of the Design QA Engineer team.

Main Responsibilities

  • Lead team of Design QA Engineers, providing mentoring, design assurance guidance, and manage resource allocations to projects.
  • Ensure all design assurance activities stay on scheduled to support Cantel Medical product development projects, and address potential issues in a timely manner to mitigate risks to project schedules.
  • Work with Cantel Medical Product Development team to execute risk based approach/procedure/plan to develop/design requirements/specifications, technical standards, test methods, test plans, test protocols and test data analysis.
  • Responsible for the identification of technical standards against QSR, EPA, EU MDD and other target market regulatory and clinical requirements.
  • Responsible for partnering with Product Development teams and Supply Chain personnel in the assessment of component and system level specifications relative to customer needs and product performance specifications.
  • Apply Design for Reliability and Manufacturability tools and techniques to ensure Cantel product designs are robust, fit Cantel’s manufacturability model, and meet customer needs.
  • Provide effective Quality Engineering support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations.
  • Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain and Manufacturing to ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ as applicable for products and processes in the concept to market phases of product development.
  • Assist in continuous improvement activities as necessary and as driven by product lifecycle management that generate Sustaining Engineering projects.
  • Prepare oral and/or written reports of analysis for Design Verification, Design Validation and other critical testing and evaluation activities, as required by the project or department management.
  • Update job knowledge by keeping abreast of trends and developments in design quality assurance, statistical analysis, test development, ISO 13485, MDD, TGA, Health Canada and FDA quality systems, and participating in educational opportunities.

Qualifications

  • BS degree required, Diploma holder in Engineering or Physics, MS degree preferred
  • 10 plus years Design Quality Assurance experience in a regulated medical device environment, specifically in a product development support role
  • 5 plus years in a leadership position
  • Experience in responsibility for compliance to FDA, MDD and ISO regulations
  • Experience in responsibility for medical device Design Verification and Validation activities
  • Experience in and responsibility for product and process risk analysis/FMEA, specification writing, test method development, statistical analysis of quantitative and qualitative data, test report writing and medical device design reviews.
  • Previous work experience in life science products or medical device fields is required
  • Proficient in computer skills such as MS office programs

 

Ideal Candidate Profile:

Personal Characteristics:

  • Strong leadership skills
  • Strong written and oral skills
  • Strong organizational and management skills
  • Strong problem solving skills
  • Strong attention to detail

Minimum Qualifications

Cantel Medical company is an Equal Employment Opportunity/Affirmative Employer. Women, minorities, veterans, and individuals with disabilities as well as other qualified individuals are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin or other protected class status.

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