Senior Design Assurance Engineer
at Integer

Date Posted: 3/25/2019

Job Description

The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.
Accountabilities & Responsibilities:

  • Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Identifies and evaluates procedures to ensure the production of quality product.
  • Develops new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
  • Applies engineering concepts to resolve acute or chronic problems.
  • Conducts studies to understand capability for process and/or measurement systems.
  • Provides management with technical guidance as required.
  • Identifies and develops appropriate documentation for process improvement and project implementation.
  • Maintains liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
  • Provides management with technical guidance as required.
  • Identifies and procures the appropriate process equipment.
  • Investigates, develops and implements new process technologies of major scope.
  • Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
  • Subject matter expert in engineering specialty/application.
  • Performs other duties as required.



Minimum Education:

  • Bachelor's degree in Mechanical Engineering or Electrical Engineering, or equivalent.



Minimum Experience:

  • 5-7 years in medical device manufacturing and design environment.
  • Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.
  • Practical knowledge of ISO 14971, ISO 62366, IEC 60601-1 and related standards
  • General familiarity with industry best practices in electrical, mechanical, SW development, testing and manufacturing processes. Medical device sterilization process
  • Experience in interpreting electrical design schematics and mechanical design drawings.
  • Preferred experience with FDA Class II, IIb and III mechanical and electro-mechanical medical devices
  • Skilled in statistical methods e.g. ANOVA, SPC, test sample size g plans, Gauge R&R, and DOE.
  • Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
  • Experience establishing and implementing quality metrics for product development.
  • Special Skills:
  • Strong collaboration, negotiation, and conflict resolution skills.
  • Excellent verbal and written communication skills.
  • ASQ CQE (Certified Quality Engineer) preferred.

Job Snapshot

About Us

Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solutions markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at www.integer.net.

Opportunities are available in the following areas:

  • Accounting
  • Engineering
  • Finance
  • Human Resources
  • Information Systems
  • Manufacturing
  • Marketing
  • Quality Assurance
  • Sales
  • Science

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