Principal Design Quality Engineer in Minneapolis

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Job DescriptionJob DescriptionSummary:

The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. Works closely with various functions, including R&D and Product Development core teams to ensure appropriate design controls are established and achievable. Also supports process development, manufacturing related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts.

Essential Duties and Responsibilities (but not limited to):

• Own creation and implementation of all design control deliverables
• Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution
• Actively participate in and contribute to core team and customer facing meetings
• Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
• Oversee risk management activities throughout the device life cycle - from product concept through post launch
• Create accurate and repeatable test & inspection methods
• Support creation and execution of biocompatibility and sterilization qualifications
• Analyze data and prepare product test reports
• Oversee content of the Design History File, its completeness and integrity
• Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections and supplier process qualifications
• Support supplier management activities and external audits
• Support external audit and certification efforts conducted by customers and regulatory bodies
• Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.
• Oversee and approve document change requests, non-conformances, deviations and special work order processes
• Lead root cause analysis and resolution activities
• Review and approve equipment specifications and qualification activities
• Develop/coach/mentor Design Quality Engineering Technicians

Essential Duties and Responsibilities (but not limited to):

• Own creation and implementation of Quality Engineering Design Control deliverables
• Mentor and assist DQE's in the creation and implementation of Quality Engineering Design Control deliverables; Mentor and coach Design Quality Engineering Technicians
• Supervise interns
• Creates and drives content of Quality Engineering Design Control deliverables
• Assist design function with the creation of User Requirements and ensure they are discrete, objective, measurable, verifiable, and traceable into Product Specifications; create product trace matrix
• Assist and help drive the design function in the creation of accurate and repeatable test and inspection methods
• Actively participate in core team and customer facing meetings; present information as needed
• Drive and oversee all risk management activities throughout the device life cycle
• Drive accurate and repeatable Test Method and Inspection methods development, Lead Test Method and Inspection method validation; analyze data and prepare test reports
• Create NCMRs as required, drive the resolution of NCMRs, drive root cause analysis for NCMRs related to product development; Track NCMR for project and report as required, Manage related CAPA, Communicate CAPA related information to customer as appropriate
• Create Quality Plan based on project needs and drive Quality Plan activities, ensure alignment with customer
• Expertise in 21 CFR 820 and ISO 13485 regulations, assists in aligning processes with regulations
• Oversee and approve document change requests, deviations, and special work order processes
• Review and approve equipment specification and qualification activities; Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plan
• Support on-time Design Verification and Design Validation and as needed Process Validation IQ/OQ/PQ/PPQ planning & execution; Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner
• Drive creation and execution of biocompatibility and sterilization qualifications
• Oversee content of the Design History File, its completeness and integrity; Audit Design History File for completeness
• Drive supplier management activities including identification of appropriate suppliers, assisting with supplier qualification, assisting with supplier audits, assisting in resolution of supplier issues, and participating in and supplier process qualifications
• Support external audit and certification efforts conducted by customers and regulatory bodies
• Support Design Quality metrics in alignment with company goals
• Support and fill in on other projects as needed

Education/Experience/Skills:

• Bachelor’s Degree in Stem Field
• Higher Level Degrees, such as MBA
• Med Device experience 10 years total, familiarity with Switchback product types
• 5 -7 years quality, 5 years design experience

Desirable qualifications below:

• Demonstrated use of quality tools and methodologies
• Strong problem solving proficiency
• Ability to manage and prioritize multiple tasks and remain focused on personal objectives
• High attention to detail and accuracy
• Proven ability to work effectively independently and on a multi-disciplinary team
• Good understanding of ISO 13485 and FDA QSR
• ISO 13485 Lead Auditor training and certification

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.

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