Job Listing
|
|
| Job ID: 14047448 |
|
| |
| Job Location: |
|
| |
|
|
| |
| How to Apply: | To see employer contact information, log in or register. |
| |
| Job Title: | Design Assurance Engineer |
| Work Type: | Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
| |
| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
| |
| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | |
| |
| Experience Required: | Unspecified |
| |
| Required Skills: | The position requires a Master’s degree or foreign equivalent degree in Life Sciences, Engineering, or a closely related field and at least 1 year (12 months) of experience in a quality or design assurance engineering position or closely related occupation in the life sciences industry; or in lieu of a Master’s degree and 12 months of experience, a qualified candidate may have a Bachelor’s degree in Life Sciences, Engineering, or a closely related field and at least 2 years (24 months) of experience in a quality or design assurance engineering position or closely related occupation in the life sciences industry. The qualified candidate must also have at least 1 year (12 months) of experience with the following: (a) quality assurance, design assurance, and/or compliance outcomes to support the achievements of organizational business objectives, and (b) regulations in the areas of FDA design control, EU MDR/MDD, FDA QSR, and ISO 13485. All experience may be gained concurrently. |
| Preferred Skills: |
|
| |
| |
| |
|
| Job Description: |
Execute quality and Design Assurance (DA) activities to support all Nonin Medical product lines and business initiatives. Determine and define quality and DA requirements to stakeholders throughout the company with emphasis on business groups strategic objectives. Ensure company products and operations comply with applicable quality and regulatory standard requirements including FDA, EU MDR and ISO 13485 requirements. Perform execution of pre-market strategic quality and DA product development activities and provide guidance and support for related post-market quality activities in collaboration with post-market team counterparts. Direct and enable compliant, efficient and risk-based execution of quality and DA strategy and supporting processes including design control, product verification/qualification, translation of VoC/clinical use environment into design inputs, external standards compliance and control, design for reliability, and design history file process owner. Execute new product development quality strategies including identification of applicable standards, design verification testing and human factors engineering. Serve as risk management owner and utilize knowledge of electrical, software and usability standards. Provide recommendations for how to overcome quality barriers and resolve any conflicts. Conduct gap assessments for remediation plans for Product Technical files, reclassification, GSPR and updating standard operating procedures (SOPs). Position requires domestic travel up to 15% as needed and customary for the occupation.
Refer to ID when applying |
|