Design Assurance Engineer II - Hardware Quality

Teleflex; Morrisville (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

Teleflex is a global medical technology company seeking a hardware design assurance professional in North Carolina to lead design controls and verification activities for capital equipment. You will partner with R&D, Regulatory, and Operations to ensure compliant designs and robust test methods.

Responsibilities include creating DHF/DMR, performing risk analyses (DFMEA/PFMEA/UFMEA), and supporting regulatory submissions and post-market actions.

Qualifications

• Hardware design assurance for new product development and sustaining projects for stand-alone capital equipment.
• Experience with design controls, risk management, test method development and validation, and design verification/validation.
• Support Regulatory Affairs with submissions.
• Develop and optimize NPD deliverables and processes across cross-functional teams.
• Translate user needs into compliant designs considering usability and human factors.
• Contribute to Technical Reviews and Design Reviews.
• Collaborate with R&D to define design inputs/outputs and manage verification/validation strategies.
• Create, review and validate test protocols; manage execution; analyze data; report DV/VID testing for hardware.
• Design test equipment and fixtures using oscilloscopes, meters, power supplies, and signal generators.
• Identify and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Maintain the product risk management file, updating with post-market information.
• Apply supplier management principles; IPC standards.
• Support regulatory approvals and regulatory questions.
• Assure quality of Sustaining Engineering processes for design and process changes.
• Review and improve design assurance QA deliverables and processes.
• Ensure transfer of NPD projects from development to production; assist with process validations and control plans.
• Produce DHF and DMR documentation per quality system.
• Assist investigations of product performance issues including NCs and CAPAs.
• Apply root cause analysis and quality tools.
• Support internal and external audits.
• Interface with cross functional groups including R&D, Program Management, Operations, QA, Regulatory, Marketing and Supplier Quality.

Responsibilities

• Fulfill hardware design assurance (i.e., quality and compliance of design) role on new product development (conception to launch) and sustaining projects for stand-alone capital equipment.
• Contribute to planning and execution of design controls, risk management, test method development and validation, and design verification/validation for new and existing products.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Develop, document, and optimize new product development deliverables and processes, accounting for cross functional system interactions.
• Understand product user needs and assure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations.
• Contribute to new product development Technical Reviews and Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships. Develop the strategy and manage the execution of design verification and validation.
• Generate, review, and validate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing related to hardware including mechanical and electrical.
• Design test equipment, test fixtures, and testing hardware using multiple types of equipment such as, oscilloscopes, meters, power supplies, and signal generators.
• Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Develop and maintain the product risk management file, including updating based on post-market information.
• Understand and assist in applying supplier management principles such as supplier selection, qualification, certification, and performance improvement. Familiarity with IPC-610, IPC-620, J-STD-001 preferred.
• Support regulatory approvals and responses to regulatory questions.
• Assure quality of the Sustaining Engineering process for design and process changes to commercialized product.
• Review and improve design assurance-specific quality system deliverables and processes to increase effectivity and efficiency.
• Assure quality in the transfer of new product development projects from development to production. Assist with process validations and control plans.
• Produce Design History File (DHF) and Device Master Record (DMR) documentation per quality system requirements.
• Support investigations of product performance issues including NC’s and CAPA’s. Utilize systematic problem solving/root cause analysis and quality and statistical tools.
• Support internal and external audits.
• Interface with cross functional groups including R&D, Program Management, Operations, Quality Assurance, Regulatory, Marketing, and Supplier Quality.

Skills

Hardware design assurance

Design controls

Risk management

Test methods

Design verification

Regulatory affairs

DFMEA

PFMEA

UFMEA

IPC standards

Supplier quality

CAPA

Audits

Cross-functional collaboration

Tools

Oscilloscopes

Multimeters

Signal generators

Job description

Teleflex is a global medical technology company seeking a hardware design assurance professional in North Carolina to lead design controls and verification activities for capital equipment. You will partner with R&D, Regulatory, and Operations to ensure compliant designs and robust test methods.

Responsibilities include creating DHF/DMR, performing risk analyses (DFMEA/PFMEA/UFMEA), and supporting regulatory submissions and post-market actions.