Design Assurance Engineer II
We do the right things and do things right 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. Duties and
Responsibilities:
-Adheres to Integer Core Beliefs 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. 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). Special Skills:
Strong written and oral communication. Minimum Education:
Bachelor's Degree in Engineering or related field Minimum
Experience:
3-5 year(s) experience
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
-Adheres to Integer Core Beliefs 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. 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). Special Skills:
Strong written and oral communication. Minimum Education:
Bachelor's Degree in Engineering or related field Minimum
Experience:
3-5 year(s) experience
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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