Design Assurance Engineer

Maclivaro Limited; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

Maclivaro Limited is seeking a Design Transfer Quality Lead for medical devices on a 12-month contract. This fully remote role requires leading a technical team to ensure design transfer activities meet regulatory and quality standards from development through manufacturing.

You will review design transfers, release deliverables, manage risk, and collaborate with R&D, Design Engineering, Manufacturing, Quality Assurance, and Regulatory Affairs to drive compliant handover to production.

Qualifications

• Engineering degree or equivalent practical experience in a relevant field.
• Strong background in medical devices and design transfer.
• Experience leading cross-functional teams in regulated environments.

Responsibilities

• Oversee design transfer quality activities and lead the team.
• Review and approve design transfer deliverables to ensure regulatory compliance.
• Provide quality leadership from design to manufacturing readiness.

Skills

Team leadership

Design transfer

Quality leadership

Regulatory compliance

Medical devices

Education

Engineering degree

Equivalent practical experience

Tools

QMS software

Risk management tools

Job description

Design Transfer Quality Lead – Medical Devices

12-Month Contract | Fully Remote | 40+ Hours per Week

Maclivaro is working with a large, national medical device and biologics company seeking an experienced Design Transfer Quality Lead to oversee and approve design transfer activities while leading a team responsible for ensuring quality, technical, and regulatory requirements are met throughout the process.

This is a highly technical, quality-focused position requiring someone with a strong engineering background and extensive experience across the medical device lifecycle, from initial design and development through to manufacturing and operational implementation.

The successful candidate will oversee a team, provide technical and quality leadership, and ensure design transfer activities are completed effectively, with all required engineering documentation, verification and validation evidence, risk assessments, and quality approvals in place before products transition into manufacturing.

We are looking for someone who can confidently engage with engineering teams, lead and support team members, challenge technical decisions where necessary, and ensure design transfer activities meet the required medical device quality and regulatory standards.

Experience with hospital imaging equipment, including X-ray machines and scanners, would be a significant advantage but is not essential.

Key Responsibilities

• Oversee and lead a team responsible for design transfer quality activities, providing direction, guidance, and technical support.
• Oversee, review, and approve design transfer deliverables to ensure they meet medical device quality and regulatory requirements.
• Provide quality leadership throughout the transition from design and development into manufacturing and operational production.
• Review and approve design transfer documentation, including design outputs, manufacturing specifications, verification and validation evidence, and associated quality records.
• Ensure design transfer plans, acceptance criteria, and deliverables are appropriately defined, documented, and completed.
• Assess technical documentation and engineering evidence to confirm products can be manufactured consistently and meet their intended design requirements.
• Work closely with R&D, Design Engineering, Manufacturing Engineering, Quality Assurance, and Regulatory Affairs teams.
• Monitor team progress, manage priorities, and ensure design transfer milestones and deliverables are achieved.
• Ensure design changes, risk management activities, and engineering modifications are appropriately assessed and controlled during the transfer process.
• Identify gaps, risks, and compliance issues, driving appropriate corrective actions where required.
• Ensure design transfer activities align with applicable FDA requirements, medical device regulations, and relevant engineering and quality standards.
• Provide technical guidance and challenge across cross-functional teams to ensure robust, compliant, and effective design transfer.
• Proven experience within the medical device industry is essential.
• A strong engineering background, ideally with a degree or equivalent practical experience in a relevant engineering discipline.
• Demonstrable experience supporting medical device design and development through to manufacturing, production, and operational implementation.
• Previous responsibility for overseeing, reviewing, or approving design transfer activities within a regulated medical device environment.
• Experience leading, supervising, or overseeing a team within a technical, engineering, quality, or medical device environment.
• Strong technical understanding of engineering principles, medical device design requirements, and relevant industry standards.
• Experience reviewing and approving engineering documentation, design outputs, verification and validation evidence, and risk management documentation.
• Good understanding of medical device quality systems, design controls, and regulatory compliance requirements.
• Ability to work confidently with engineering teams, understand technical detail, and make sound quality-related decisions.
• Experience working cross-functionally across Design Engineering, Manufacturing Engineering, Quality, and Regulatory Affairs.
• Experience with medical imaging equipment, including hospital-based X-ray systems, CT scanners, or other diagnostic imaging technologies.
• Experience transferring complex electromechanical or software-enabled medical devices into manufacturing.
• Familiarity with relevant medical device standards and regulations, including ISO 13485, ISO 14971, IEC 60601, and applicable FDA requirements.
• Experience supporting manufacturing readiness, process validation, and production handover activities.

Experience with X-ray systems or hospital imaging equipment would be a real advantage, but candidates with strong medical device engineering, team leadership, and design transfer experience from other product areas will also be considered.

• Hours: 40+ hours per week
• Location: Fully remote
• Engagement: Contract
• Industry: Medical Devices / Biologics