The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Myq82k67jl0lwvf8xvn

Design Assurance Engineer II

Job Description

The primary purpose of this position is to support new product development activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and the Company's Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design concept phases through launch.
Integer's Cardiac Rhythm Management & Neuromodulation product category is hiring for a Design Assurance Engineer II at our Plymouth, MN facility.

Key Accountabilities and Responsibilities

  • Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
  • Generates and/or reviews related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports.
  • Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
  • Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods.
  • Coordinates the preparation of Quality Plans, including inspection and gauge requirements.
  • Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required.
  • Coordinates sourced item qualification activities and supports supplier risk management initiatives.
  • Performs other functions as required.

Job Requirements

  • Minimum Education: Bachelor's Degree in Engineering or related field
  • Minimum Experience: 2-5-year(s) experience

Specialized Knowledge:

  • Experience with statistical software packages such as Minitab.
  • Demonstrated problem solving skills.
  • Knowledge of ISO and FDA quality, process validation and system requirements
  • Experience in interpreting design schematics and drawings
  • Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE.
  • Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
  • Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment.

Job Requirements

 

Job Snapshot

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

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
Rena Buckley
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 position is to support new product development activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and the Company's Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design concept phases through launch.
Integer's Cardiac Rhythm Management & Neuromodulation product category is hiring for a Design Assurance Engineer II at our Plymouth, MN facility.

Key Accountabilities and Responsibilities

  • Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
  • Generates and/or reviews related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports.
  • Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
  • Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods.
  • Coordinates the preparation of Quality Plans, including inspection and gauge requirements.
  • Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required.
  • Coordinates sourced item qualification activities and supports supplier risk management initiatives.
  • Performs other functions as required.

Job Requirements

  • Minimum Education: Bachelor's Degree in Engineering or related field
  • Minimum Experience: 2-5-year(s) experience

Specialized Knowledge:

  • Experience with statistical software packages such as Minitab.
  • Demonstrated problem solving skills.
  • Knowledge of ISO and FDA quality, process validation and system requirements
  • Experience in interpreting design schematics and drawings
  • Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE.
  • Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
  • Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment.

Job Requirements

 
Mwr1k875wzts0yxgjcl
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Design Assurance Engineer II Apply now