Design Assurance Engineer

Cure Talent; Saxmundham; On-site; USD 53,533 - 93,683; Full time

Job summary

An innovative medical device manufacturer is seeking a Design Assurance Engineer to join its expanding product development team. This role offers a unique opportunity to contribute to the development of new medical devices, ensuring they meet stringent regulatory and quality standards. The ideal candidate will possess a degree in engineering or a related field, along with experience in medical device design assurance and regulatory compliance. You will oversee design assurance activities, manage documentation, and collaborate closely with quality teams. If you're eager to make a difference in health technology, this is the perfect opportunity for you.

Qualifications

• Experience in medical device design assurance and regulatory compliance.
• Strong knowledge of design control processes and documentation.

Responsibilities

• Oversee design assurance activities for regulatory compliance.
• Manage design control documentation and risk management processes.
• Support design verification and validation activities.

Skills

Design Assurance

Regulatory Compliance

Quality Engineering

Analytical Skills

Education

Degree in Engineering

Degree in Science

Related Technical Field

Tools

ISO 13485

Risk Management Processes

Job description

Cure Talent is delighted to be working with an innovative and well-established medical device manufacturer who is seeking a Design Assurance Engineer to support its growing product development team.

This is an exciting opportunity to contribute to the development and introduction of new medical devices, ensuring compliance with regulatory and quality standards.

Key Responsibilities:

1. Oversee design assurance activities to ensure compliance with regulatory and quality standards
2. Manage design control documentation, technical files, and risk management processes
3. Support design verification and validation activities, including test planning and analysis
4. Work closely with regulatory and quality teams to ensure successful product registration and compliance with ISO 13485 and other relevant standards
5. Assist in process validation and manufacturing transfer to ensure product quality and performance
6. Participate in internal and external audits, addressing corrective actions where necessary

The ideal candidate will have:

1. A degree in engineering, science, or a related technical field
2. Experience in medical device design assurance, quality engineering, or regulatory compliance
3. Strong knowledge of design control processes and documentation requirements
4. Familiarity with ISO 13485 and other relevant medical device regulations
5. Experience in risk management, verification and validation, and technical documentation
6. Strong analytical skills with the ability to interpret complex data and ensure compliance

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance and Design

Industries

Medical Equipment Manufacturing