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Sr. Design Assurance Engineer

Job Description

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.
Integer's Cardio & Vascular product category is hiring for a Sr. Design Assurance Engineer at our Chaska, MN facility. Below are details on this exciting opportunity.



Key Accountabilities and Responsibilities

  • Adheres to GB Core Beliefs and all safety and quality requirements.
  • As a quality Core Team member actively participates in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
  • Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Prepares required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device.
  • Coordinates with R&D in DAE review of technical documentation, develop test methods and prepare design verification and validation test deliverables. Plans and conducts compliance testing to recognized international standards.
  • Coordinates with Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
  • Provides support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs
  • Performs other functions 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.
  • Specialized Knowledge:
  • 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-Chaska
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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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
Rena Buckley
Snapshot
Integer Holdings Corporation
Company:
US-MN-Chaska
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.
Integer's Cardio & Vascular product category is hiring for a Sr. Design Assurance Engineer at our Chaska, MN facility. Below are details on this exciting opportunity.



Key Accountabilities and Responsibilities

  • Adheres to GB Core Beliefs and all safety and quality requirements.
  • As a quality Core Team member actively participates in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
  • Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Prepares required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device.
  • Coordinates with R&D in DAE review of technical documentation, develop test methods and prepare design verification and validation test deliverables. Plans and conducts compliance testing to recognized international standards.
  • Coordinates with Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
  • Provides support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs
  • Performs other functions 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.
  • Specialized Knowledge:
  • 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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Sr. Design Assurance Engineer Apply now