Senior Design Assurance Engineer

Rhian_Convatec; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Join a pioneering medical solutions company as a Senior Design Assurance Engineer, where you will lead the design control and risk management processes. This role offers a unique opportunity to enhance product development while collaborating with a diverse team. You will be instrumental in ensuring compliance with industry standards and improving operational efficiencies. With a commitment to innovation and excellence, this forward-thinking organization provides an environment that supports your professional growth and encourages you to make a meaningful impact in the lives of patients worldwide. Embrace the challenge and be part of a transformative journey.

Qualifications

• 5+ years of experience as Design Assurance Engineer in a Medical Device company.
• Experience with EU ISO 13485 and US 21CFR820 standards.

Responsibilities

• Drive adherence to design control and risk management processes.
• Involved in planning and follow-up of design control activities.
• Review and approve project activities for compliance.

Skills

Design Control

Risk Management

Quality Management System (QMS)

Regulatory Standards

Requirements Engineering

Usability Engineering

Education

Master's or Bachelor's degree in Engineering

Technical Science

Laboratory Science

Job description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more about Convatec, please visit http://www.convatecgroup.com

Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Senior Design Assurance Engineer and you’ll do the same.

As a Senior Design Assurance Engineer, you will drive the subject matter expertise of our Design Control process, as well as our Risk Management process and participate in improvement of our processes, support the product documentation during all phases of NPD projects and review essential parts of the technical documentation. You will be part of our global Quality organization with a strong professional foundation.

Key Responsibilities:

• Driving adherence to the design control as well as risk management processes in product development projects.
• A key figure in the planning and follow-up of all design control activities.
• Involved in all project activities, through review and approval to ensure compliance to our standard operating procedures and instructions as well as external standards and regulations.
• Involved in assessing, developing, and continuously improving the standard operating procedures, instructions, and templates, in the context of risk management and product development.

Skills & Experience:

• You bring extensive experience from a similar role as Design Control Engineer or Product Quality Engineer, in new product development or in remediation, driving the design control activities within a Medical Device company.
• You may have worked in a maintenance of Quality Management System (QMS) process’s role, looking after the process, as well as technical documentation preparation.

To be truly successful in this position,

• You understand that key contributing factors to success are cooperation and building strong collaboration with other functions, like Global Quality, R&D, RA, Process Engineering and Production.
• You communicate easily to achieve a common goal and at the same time deliver high quality and timely solutions and deliverables.
• You appreciate thoroughness and correctness as a natural focus of the daily work.
• Working in a dynamic environment, you know how to drive and follow up on the cross-functional team’s contributions to the design control documentation, prioritizing your tasks to meet the agreed project timelines and adherence to the process.

Qualifications/Education:

• You hold a master’s or bachelor’s degree in engineering, pharmacy, technical science, or similar technical diploma in laboratory science.
• Proven 5 years of experience as Design Assurance Engineer or similar.
• Proven experience with maintenance and development of QMS processes or design control processes within new product development in Medical Device context.
• Hands-on experience with Design Control in accordance with EU ISO 13485, US 21CFR820, ISO 14971 and MDR.
• Experience with requirements engineering, product risk management, and usability engineering.
• Knowledge within regulatory legislation and standards.
• Preferable knowledge within Medical Device product development (Class II).

Team:

• You will be part of a team of 14 highly competent colleagues belonging to our global Quality organization with a strong professional foundation.
• You will work in collaboration with a cross-functional project team, and key stakeholders from R&D, QA Infusion Care and Design Assurance, Global Quality in a world leading company specialized in treatment of chronic diseases such as Diabetes and Parkinson’s Disease.

Travel Requirements:

You can expect up to 10 travel days per year, primarily travels to our manufacturing sites in Reynosa (MX), Deeside (UK), and Osted (DK).

Languages:

• Speaking: English
• Writing/Reading: English
• Danish and Spanish are nice to have, as the Infusion Care sites are in Denmark and Mexico.

Working Conditions:

This role may be based in the United Kingdom with a remote working structure - office presence will be required or allowed for certain meetings, events, or to meet certain business needs.

Our transformation will change your career. For good.

You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life.

There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.
This is work that’ll move you.

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#LI-Remote