Director Development

BONESUPPORT AB is a leading Scandinavian biotechnology company based in Lund, Sweden. BONESUPPORT AB aims to become a global leader in orthobiologics by optimizing bone biology to treat bone disorders. BONESUPPORT AB develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs. BONESUPPORT's bone graft substitutes are based on the patented technology platform CERAMENT .

BONESUPPORT is searching for their next

The role is a great opportunity to join BONESUPPORT AB's dynamic and rapidly growing team.

The vision of the Development & Engineering organization is to efficiently take concepts through the product development process, ensure lifecycle management matching regulatory and competitive requirements and facility well managed design transfers of new products into Operations.

As the Director Development & Engineering, you are responsible to ensure product lifecycle management of current commercial products and for the development of new products in line with company strategy. The team is in addition responsible for technical documentation, verifications and validation activities, risk management, usability, labelling and sterilization activities.

You will lead a very professional team of six senior individuals, with strong competencies within design control, design & engineering, biological safety and risk management. Hands-on assignments will also be a part of the daily work.

The main missions of this role:

• Overall responsibility for Design Controls, Risk Management, Usability Engineering and Change Controls
• Lead and motivate the Development team to achieve its objectives and being a high performing team
• Structure, plan and lead the work within Development & Engineering
• Ensuring product lifecycle management of current product
• Responsible for changes required for commercial products
• Development of new products in line with company strategy
• Collaborate tightly with other core functions.

This position is based at the headquarters in Lund and reports to EVP R&D and Operations.

Profile

• M.Sc. degree within engineering or chemistry
• Minimum 8 years relevant experience in medical device and/or pharma
• Proven leadership and management experience
• Experience with medical devices class II and class III preferred
• Experience with medical device combination products preferred
• Experience with taking medical devices through the development pipeline according to design control requirements for CE marking and/or FDA approval.
• Experience in Design transfer / implementation of a new products in Manufacturing.
• Experience from working with lifecycle management of product portfolio
• Experience from and understanding of design control, risk management, CAPA investigation, labelling, requirements, and qualification/validation documentation at a level adequate for regulatory submissions Notified Body / FDA.

Experience, knowledge, skills

The right candidate has experience from leadership and working with medical device and preferably products with active substances. You have worked with development / engineering of products and has an understanding of the end-to-end process of medical device product development/lifecycle management. You are driven by developing others and creating well performing teams.

Personality

As a person you are people-oriented and a true team player. You are solution and business oriented and able to keep deadlines and deliver in a high pace environment. Since BONESUPPORT is in growth phase you need to be structured and able to set processes for others to succeed. Further you are hands-on in your approach and have the ability to go from in-depth details to the overall perspective. We believe you have a holistic view and an analytic capability; you can review large amounts of information and make relevant priorities. You are persistent, focused and can balance detail, overview and quality.

Why BONESUPPORT?

At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance – which is reflected in impressive employee engagement figures. We believe in our journey and take pride in what we do.

Information and application

In this role we are cooperating with Ethel Executive. For more information about this job-opening, please contact Emma Lindén or Louise Brondin Månsson

Welcome with your application Send your CV (as soon as possible since we are reviewing applications continuously) and a few lines on what motivates you to apply for the role and why you want to join BONESUPPORT.