Sr. Design Assurance Engineer at Comtec Consultants

Sr. Design Assurance Engineer

Pittsburgh, PA onsite/hybrid

12 Months

Key Areas of Responsibility (KARs):

• Ensures that appropriate quality, reliability and Post Market-Surveillance (PMS) plans are made and include all stages of the product life cycle
• Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone.
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required
• Supports stakeholders during the execution of quality system and product audits and inspections.
• Required Competencies:

• DESIGN quality experience. Sustaining product changes, product development (design inputs, design outputs, hazard analysis, design verification, design validation, design transfer, analysis of impact to quality/safety of design changes, coaching teams through use of design controls), DHF remediation.
• Quality Management
• Risk Management
• Design Controls and change Management
• Quality Assurance
• Quality Engineering
• Verification/ Validation- Design Transfer

Education and Experience Requirements:-

• Bachelors degree in engineering
• Working knowledge of appropriate global regulations, requirements, and standards.
• 3 years of related experience in a medical device or other regulated industry.

Job Overview:

• Independently Produces and completes Quality Engineering Documents.
• Responsible for performing timely, quality engineering tasks like: Assessing quality plans, assessing product designs, and reviewing test and other performance data, analyzes market feedback, lead root cause analysis and quality problem solving.
• May also provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Fully qualified quality engineer who has advanced beyond entry level.
• Has working knowledge of company products and services.
• Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules
• Works on issues of diverse scope where analysis of situation of data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
• Acts as advisor to junior quality engineers
• Collaborates with the following main stakeholders with regards to the KARs: R&D Engineers, Post Market Surveillance investigators, Risk Management engineers, Product Support Engineers, Regulatory Affairs Specialists, Quality Manufacturing Engineers, Product Industrialization Engineers, Supplier Quality Engineers, Reliability Engineers
• Within NPI and Sustaining Projects, supports all ongoing Project activities e.g. coordinates Quality Norm planning activities, reviews and approves design deliverables and guides the Project Team regarding open Process/Quality questions.