Senior Design Control Specialist

We are expanding our capabilities in the Design Control team and therefore we are looking for a Senior Design Control Specialist to conduct the design control activities on one of our most significant projects.
Your role

As a Senior Design Control Specialist, you will play a key role in managing and conducting the design control activities for new and existing products. You will work closely with cross-functional teams including engineering, regulatory, and quality assurance to ensure that design control processes are efficiently followed, and all design documentation is accurate, complete, and compliant with industry standards and regulatory guidelines.

Your key responsibilities

• Develop and maintain design control documentation throughout the product lifecycle from concept to commercialization.
• Develop and maintain design history files (DHF) and ensure that they meet all regulatory requirements (e.g., FDA, ISO).
• Collaborate with engineering, quality, regulatory, and product development teams to ensure product designs are compliant with applicable standards.
• Facilitate risk management activities including system risk analyses, failure mode and effects analysis (FMEA), and implementing risk mitigation strategies.
• Facilitate and follow up on design reviews and outcomes.
• Support project progression by drafting and creating technical justifications, memos, and other necessary documentation to facilitate informed decision-making and regulatory compliance.
• Monitor and ensure that all design-related changes are correctly documented, reviewed, and approved.
• Support the preparation for regulatory submissions by providing relevant design documentation and reports.
• Maintain knowledge of relevant regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and others applicable to design control.

As a consultant, you will work on diverse projects ranging from start-ups to industry leaders, some days from the office in Hørsholm, some days onsite at the clients and some days remote. You thrive in the diverse tasks of design control, from defining early requirements and managing risks to conducting design reviews and supporting verification and validation. Guided by a well-structured design and development plan, you prepare detailed technical documentation and enjoy refining processes, updating templates, and driving excellence in regulatory compliance and design best practices.

And by the way: being a consultant at Technolution is not the equivalent of being a lone wolf. You will always be part of a team; at the client’s or at Technolution.

Your qualifications

You are a Design Control Specialist with solid experience within Pharma or MedTech, always eager to put your skills at use and collaborate with equally passionate colleagues, to grow a shared understanding and spike the learning curve.

• MSc or BSc in Engineering (e.g., mechanical, biomedical etc.) or similar
• At least 3 years of experience working with Design Control.
• Specific knowledge around ISO 11608 and conducting design reviews, design transfer, change control and development of design outputs is beneficial but not required
• Professional proficiency in English

Want to know more
Are you intrigued and want to know more about the position you can reach out to Mathias Nørbæk Bjerring at 28 99 39 60 or [email protected].

How to apply

Skip the formal cover letter and apply using your CV. Leave out the photo as well, as we would like to see you when we meet in person.

The way we work is our mark – tn

We are a hub of knowledge, crisscrossing, and innovation. We are more than 100 nice and nerdy consultants – young talents and experienced professionals – working no more than 37 hours a week, always as part of a team and with no pressure for selling out competencies. What we share is a great team spirit, honesty, and respect – altogether fostering a great culture of good relationships.

Meet Technolution

Technolution is a growing consultancy within Pharma and MedTech teaming up with clients to develop innovative and life-improving medical devices. We are based in Hørsholm in charming surroundings, most of our clients are located near Copenhagen, and our colleagues are switching between on-site and remote work.

Our areas of expertise enable us to assist our clients in all stages of the product development cycle, bringing high tech skills with a human touch. Over the past 20 years, Technolution has developed a culture of trust and professionalism, reflected in our increasing number of new and returning clients – from small startups to some of the largest players in the field.

Department: People & OrganizationDeadline: 29 December 2024