Job Title: Sr. Design Assurance Engineer

Job Description

The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Working with cross-functional development teams, you will establish and maintain design control deliverables, risk management activities, and DHF compliance to ensure the delivery of the highest quality product to the customer.

Responsibilities

• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
• Lead and ensure the on-time completion of protocols, reports, and assigned project deliverables.
• Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory/standards compliance; collaboratively communicate and resolve gaps.
• Support and ensure internal and external audit responses and on-time product re-certifications.
• Establish objective, measurable, discrete, and verifiable customer and product requirements.
• Define objective component specifications, develop supplied component sampling plans, and qualify vendors.
• Provide support for biocompatibility and sterilization qualifications.
• Develop and lead other team members, providing work direction to 2-3 technicians assigned for inspection, testing, and project support.
• Perform other functions as required.

Essential Skills

• BS in Industrial Engineering, Engineering, or Business Degree
• 8-15 years of experience in medical device Quality Operations or equivalent experience
• Comprehensive understanding of FDA regulations

Additional Skills & Qualifications

• Statistical and data analysis skills
• Supervisory, solid management, and strong leadership experience