Design Quality Engineer II

About the Role

This on-site position in Memphis, TN supports all quality engineering activities throughout the new product life cycle—from concept to commercialization and sustaining activities. The Design Quality Engineer II serves as the quality engineering contact and a key member of cross-functional development and sustaining teams, ensuring compliance with ISO, EU MDR, and FDA QSR requirements for medical devices. The role leads quality initiatives with inter-organizational impact, following QSR, CONMED policies, standards, and regulations.

Responsibilities

• Supports and provides direction to product development teams for required quality deliverables.
• Ensures product design meets customer expectations, regulatory requirements, voluntary standards, and corporate requirements, with a focus on continuous improvement.
• Reviews, assesses, and approves product design documentation to ensure compliance throughout the product development cycle.
• Reviews and approves engineering designs/changes for quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• Troubleshoots and directs the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships, with a relentless focus on the safety and efficacy of medical devices.
• Reviews and approves design verification and validation protocols and reports, ensuring design inputs and user needs are adequately addressed.
• Leads and supports risk management activities with a focus on clinician and patient safety.
• Supports product development through capability assessment, performance data analysis, problem-solving facilitation, and development of quality tools and techniques.
• Supports sustaining activities such as complaint investigation and trending, manufacturing and service trend monitoring, predicate device reviews, and surveillance reports.
• Performs data mining, analyzes data, and creates trend reports.
• Demonstrates quality assertiveness and represents the Quality function in product support and lifecycle management.
• Investigates process and product issues identified through complaints and trend analysis, working with other functional groups to resolve quality problems.
• Directs and facilitates investigations, preventative actions, and corrective actions resulting from abnormal results, customer complaints, or other quality performance indicators.
• Supports internal and external audits, including preparation activities and back-room participation.
• Travel requirements: 0-5% (including international).

Requirements

• B.S. degree in Engineering (Electrical, Mechanical, or Biomedical) and 2+ years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience.
• Ability to interpret and apply Quality Systems Regulations and ISO quality requirements, staying abreast of new industry standards and concepts.
• Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Capability to plan schedules and manage multiple projects simultaneously.
• Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
• Design for Six Sigma training and knowledge of statistical methodologies are desired.
• Experience in back-room support during external audits/inspections and reviewing design verification/validation protocols.
• Excellent communication, problem-solving, organizational, and interpersonal skills.
• Strong technical writing skills and ability to work independently with minimal direction or supervision.

Physical Requirements

• Ability to sit/stand for 8 hours.
• Ability to sit at a computer terminal for extended periods.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits

• Competitive compensation.
• Comprehensive healthcare coverage (medical, dental, vision, and prescription).
• Short- and long-term disability plus life insurance (fully employer-paid).
• Retirement Savings Plan (401K) with dollar-for-dollar employer matching (up to 7% per pay period).
• Employee Stock Purchase Plan with discounted stock purchases.
• Tuition assistance for undergraduate and graduate-level courses.
• Employee Referral Program incentives.