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Senior Design Assurance Engineer (Test Validation)

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 is hiring for a Sr. Design Assurance Engineer supporting our Cardio & Vascular group. The ideal candidate would have strong experience in Test Design, Development and Validation, strong project management skills, and have experience working in a regulated industry environment.



Accountabilities & Responsibilities:

  • Design and maintain product assurance programs to effectively develop and approve new product.
  • Plan and delegate to Design Engineering staff in order to accomplish project goals.
  • Provide leadership to achieve a better design process, more efficient design reviews, and improved design challenge testing. Lead early avoidance of potential design defects.
  • Prepare validations, verifications, risk analysis and similar product assurance activities.
  • Prepare, review and analyze design history documents to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer guidelines. Ensure accurate and complete design records are maintained.
  • Work with regulatory affairs staff to prepare regulatory submissions and reports to FDA, ISO, PMDA and other regulatory authorities.
  • Compile and prepare technical information for customer distribution.
  • Communicate with customers and product users to define product performance and safety requirements. Evaluate and respond to customer complaints and concerns on new and pilot products.
  • Provide Quality/Design Assurance engineering support for pilot, pre-production and production lines.
  • Participate in product development projects as a primary team member. Educate team personnel on policy and practice on a continuous basis.
  • Represent the Product Assurance engineering department at planning and other management meetings in absence of the manager; act as a liaison between management and subordinates to keep personnel informed on technical matters, decisions and policies.
  • Keep informed of developed pertaining to inspection techniques, tooling, and training that would be of assistance to Integer or production departments. Actively participate in making recommendations for improvements.
  • Interview and participate in Quality/Design Assurance personnel selection as required.
  • Apply continuous improvement/lean concepts to identify and eliminate non-value added tasks and/or other activities
  • Perform other duties as assigned.



Education & Experience:

  • Bachelor's degree in related Engineering field. Masters degree preferred.
  • Minimum 7+ years of experience in a Design Assurance / Quality discipline
  • Medical Device experience preferred





Job Requirements

 

Job Snapshot

Location US-MN-Chaska
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-Chaska
Kaz Abidi
(716) 759-5600
Snapshot
Integer Holdings Corporation
Company:
US-MN-Chaska
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 is hiring for a Sr. Design Assurance Engineer supporting our Cardio & Vascular group. The ideal candidate would have strong experience in Test Design, Development and Validation, strong project management skills, and have experience working in a regulated industry environment.



Accountabilities & Responsibilities:

  • Design and maintain product assurance programs to effectively develop and approve new product.
  • Plan and delegate to Design Engineering staff in order to accomplish project goals.
  • Provide leadership to achieve a better design process, more efficient design reviews, and improved design challenge testing. Lead early avoidance of potential design defects.
  • Prepare validations, verifications, risk analysis and similar product assurance activities.
  • Prepare, review and analyze design history documents to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer guidelines. Ensure accurate and complete design records are maintained.
  • Work with regulatory affairs staff to prepare regulatory submissions and reports to FDA, ISO, PMDA and other regulatory authorities.
  • Compile and prepare technical information for customer distribution.
  • Communicate with customers and product users to define product performance and safety requirements. Evaluate and respond to customer complaints and concerns on new and pilot products.
  • Provide Quality/Design Assurance engineering support for pilot, pre-production and production lines.
  • Participate in product development projects as a primary team member. Educate team personnel on policy and practice on a continuous basis.
  • Represent the Product Assurance engineering department at planning and other management meetings in absence of the manager; act as a liaison between management and subordinates to keep personnel informed on technical matters, decisions and policies.
  • Keep informed of developed pertaining to inspection techniques, tooling, and training that would be of assistance to Integer or production departments. Actively participate in making recommendations for improvements.
  • Interview and participate in Quality/Design Assurance personnel selection as required.
  • Apply continuous improvement/lean concepts to identify and eliminate non-value added tasks and/or other activities
  • Perform other duties as assigned.



Education & Experience:

  • Bachelor's degree in related Engineering field. Masters degree preferred.
  • Minimum 7+ years of experience in a Design Assurance / Quality discipline
  • Medical Device experience preferred





Job Requirements

 
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