Design Assurance Engineer

Company Overview

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. MEC’s vision is to closely align clients’ needs with the best resources available, taking proactive, preventative, and corrective action to create roadmaps for ongoing improvement, validate processes, ensure fully compliant quality systems, and close gaps between current and FDA‑expected stages. MEC offers short‑ or long‑term support ranging from senior leaders and consultants to engineering staff and subject‑matter experts.

Job Purpose

The role focuses on design assurance and quality engineering within new product development, operations, and system/services support for a large medical device company. The incumbent will develop, establish, and maintain quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.

Key Responsibilities

• Provide leadership on departmental or cross‑functional engineering initiatives.
• Offer project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigate, identify, and implement best‑in‑class quality engineering practices.
• Mentor technical staff in identifying and resolving quality issues.
• Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing of products.
• Lead implementation of assurances, process controls, and CAPA systems to meet or exceed internal and external requirements.
• Act as an effective leader or team member supporting quality disciplines, decisions, and practices.
• Apply systematic problem‑solving methodologies to prioritize, communicate, and resolve quality issues.
• Assure development and execution of streamlined business systems that effectively identify and resolve quality issues.

Quality Systems Duties

• Build quality into all aspects of work by maintaining compliance with all quality requirements.

Qualifications

• Minimum 5 years of experience with design history file (DHF), risk management, and post‑market complaint processes for medical devices.
• Experience in design quality roles, interventional cardiology, and within a large medical device company.
• Prior experience with the client’s quality system is highly desired.
• 9–13 years of experience with a BS degree, or 7–11 years with an MS degree, or 4–8 years with a PhD.

Applicants must be authorized to work in the United States in accordance with applicable law; this position is not eligible for employer‑sponsored work authorization now or in the future.

Other duties may be assigned, and the job description is not intended to be an exhaustive list of all responsibilities. Duties, responsibilities, and activities may change at any time with or without notice.

MEC does not accept unsolicited resumes from search firms or staffing agencies; such resumes will be considered the property of Medical Engineering Consultants.