Design Quality Engineer II

Haemonetics

315d

About The Position

The Design Quality Engineer II is accountable to support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control. The Design Quality Engineer II will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management.

Requirements

• Bachelor's Degree in Electrical, Biomedical, Mechanical, other equivalent technical engineering discipline (Advanced degree, Masters or PhD, substitute 2 years' experience below)
• 3+ years in a medical device or equivalent regulated environment and Design Quality Engineering or equivalent design experience required
• Familiar with Microsoft Word, Microsoft Project, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Adobe Acrobat (required)

Nice To Haves

• Professional certification as one or more of the following: Certified Quality Engineer, Certified Reliability Engineer, Certified Six Sigma Green Belt (preferred)

Responsibilities

• Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects
• Manage project quality plans
• Support translation of Voice-of-Customer into development Requirements
• Support development team in creation, review, and approval of engineering Requirements & Specifications in accordance with standard operating procedures
• Facilitate cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), Fault Tree Analysis (FTA)
• Support development team in creation, review, and approval of engineering development plans & test plans
• Support development team in creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation
• Support development team in creation, review, and approval of critical-to-quality specifications
• Support development team in creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing
• Support measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods
• Review & provide guidance on statistical testing methods and sampling in support of verification and validation testing
• Ability to support 1 or more Product Line Portfolios
• Ensure accuracy and completeness of the Design History File and the Device Master Record
• Compile, review, and analyze failure data to provide feedback to the development team
• Ensure compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions
• Support and administer quality system elements including but not limited to: Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc.
• Support continuous improvement projects and reviews of policies, procedures, instructions, and training
• Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections
• Lead or participate in problem solving and other work improvement activities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Plastics and Rubber Products Manufacturing
• Education Level: Bachelor's degree