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Senior Design Assurance Engineer

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.
Integer's Cardio & Vascular product category is hiring for a Sr. Design Assurance Engineer at our Plymouth Facility.

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 Requirements

 

Job Snapshot

Location US-MN-Plymouth
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace, Other
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Company Overview

Integer Holdings Corporation

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, marital status, or any other legally recognized protected basis under federal, state or local law. Greatbatch will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel you need a reasonable accommodation pursuant to the ADA, please contact us at 716-759-5412. Learn More

Contact Information

US-MN-Plymouth
Kaz Abidi
(716) 759-5600
Snapshot
Integer Holdings Corporation
Company:
US-MN-Plymouth
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace, Other
Store Type:

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.
Integer's Cardio & Vascular product category is hiring for a Sr. Design Assurance Engineer at our Plymouth Facility.

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 Requirements

 
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Senior Design Assurance Engineer Apply now