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Design Assurance Engineer

Integer Holdings Corporation • Chaska, MN

Posted 6 days ago

Job Snapshot

Full-Time
Experience - At least 3 year(s)
Degree - 4 Year Degree
Manufacturing
QA - Quality Control
0

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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 Company Policies & Procedures. This position will ensure a successful transfer of newly developed products to production, while supporting design phases concept through launch.

Key Accountabilities and Responsibilities

  1. Adheres to GB Core Beliefs and all safety and quality requirements.
  2. Acts a quality Core Team member and 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.
  3. Generates and/or reviews related project deliverables, such as Master Validation plans for new products, design verification and design validation protocols and reports; and process validation protocols and reports.
  4. Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
  5. Supports Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods.
  6. Coordinates the preparation of Quality Plans, including inspection and gauge requirements.
  7. Provides support for root cause analyses, preparation of CAPA and HHA. Updates SOPs as required.
  8. Coordinates component qualification activities and supports supplier risk management initiatives.
  9. Performs other functions as required.

Job Requirements

  • Minimum Education: Bachelor's Degree in Engineering or related field preferred or, in lieu of degree, an additional two years of experience for every year of education.
  • Minimum Experience: 3-5 years of experience in a related field
  • Specialized Knowledge:
  • Experience with statistical software packages such as Minitab.
  • Demonstrated problem solving skills.
  • Knowledge of ISO and FDA quality and system requirements, process validation.
  • Experience in interpreting electrical design schematics and mechanical design drawings.
  • Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R, and DOE.
  • Experience with quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
  • Special Skills: Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment.

Job Requirements

Job Requirements

Minimum Education: Bachelor's Degree in Engineering or related field preferred or, in lieu of degree, an additional two years of experience for every year of education.
Minimum Experience: 3-5 years of experience in a related field
Specialized Knowledge:
Experience with statistical software packages such as Minitab.
Demonstrated problem solving skills.
Knowledge of ISO and FDA quality and system requirements, process validation.
Experience in interpreting electrical design schematics and mechanical design drawings.
Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R, and DOE.
Experience with quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
Special Skills: Strong written and oral communication skills, including technical writing. Demonstrated a
Job ID: 4298
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