Design Assurance Engineer

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 atrisk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 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 Design Assurance Engineer and you’ll do the same

As Design Assurance Engineer, you will drive the subject matter expertise of our Design Control process, as well as our Risk Management process to 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 organisation with a strong professionally foundation.

Key Responsibilities:

Within one or more product development projects or remediation projects you will be:

• 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 1-2 years experiences as Design Assurance Engineer or similar
• Preferably 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 in Medical Device product development (Class II)

Dimensions:

Team

• You will be part of a team of 14 highly competent colleagues belonging to our global Quality organisation with a strong professionally 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 specialised in treatment of chronic diseases such as Diabetes and Parkinson’s Disease.

Principal Contacts & Purpose of Contact

• For NPD-projects your main contacts will be Project Manager, Design and Test Engineers, R&D Infusion Care, as well as Regulatory Specialists
• For QMS and compliance, main contacts will be Quality Engineers from QA Infusion Care, as well as Design Assurance, Global Quality

Travel Requirements

You can expect up to 10 travel days per year, primarily travels to our site in Mexico or Denmark.

Languages

• Speaking: Yes English*

• Writing/Reading: Yes English*

• Danish is nice to have, as the Infusion Care sites are in Denmark and Mexico

Working Conditions

You will report to the Senior Design Assurance Manager Infusion Care, located in Denmark.

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.

#LI-DS4

#LI-Onsite

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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