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Software Design Quality Engineer

Iconma

Westford, MA

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JOB DETAILS
SKILLS
Atlassian JIRA, Cross-Functional, Design Verification, Environmental Management Systems, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Health Plan, Healthcare, Implants, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Process Development, Process Manufacturing, Product Design, Product Development, Product Support, Product/Service Launch, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulations, Regulatory Requirements, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Software Design, Statistics, Sterilization, Technical/Engineering Design, Test Plan/Schedule, Time Management, Validation Plan, Validation Testing, Vendor/Supplier Planning
LOCATION
Westford, MA
POSTED
10 days ago
Our Client, a Medical Device and Healthcare company, is looking for a Software Design Quality Engineer for their Westford, MA location.
 
Responsibilities:
  • Lead and/or support on-time completion of Design Control deliverables
  • Support the establishment of objective, measurable, and verifiable product requirements
  • Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
  • Lead Risk Management activities from product concept through commercialization
  • Support test method development and lead test method validation activities
  • Support manufacturing process development & qualification for new product and design changes
  • Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support biocompatibility and sterilization qualifications
  • Support audits and quality system improvement activities
  • Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Comply with client, U.S. FDA, EUMDR and other requirements, as applicable.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
 
Requirements:
  • Bachelor’s degree in Engineering or Technical Field.
  • Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
  • Experience in medical devices and associated regulations/standards.
  • Experience in test method development and validation
  • Experience in preparing risk assessments, FMEA and other risk documents.
  • Preferred Qualifications:
  • Advanced Degree in Engineering/Technical Field
  • Experience in active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
  • Working knowledge of statistics and its application to verification and validation"
 
Why Should You Apply?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
 
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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