With innovation at the center of everything we do, we design and deliver the active drug product (including formulations, devices and packaging) required to support new medicines – from products to be used in toxicology studies and clinical trials to development of the technology to ensure that drug products can be scaled up for manufacturing on a commercial scale.
Inhalation Product Development (IPD) Device & Packaging Gothenburg is a team within Pharmaceutical Technology and Development (PT&D) and our team focuses on designing and developing devices for inhalation drug administration and packaging of pharmaceuticals and devices.
We are looking for a Team Leader for Senior Medical Device Design Engineers to lead the mechanical design of a drug delivery device. You will lead a team of design engineers and external partners through the entire product development process, from concept generation to final commercial design. You will represent mechanical design in a cross functional design core team.
You will play a role in defining processes and methods to ensure timely and qualitative output from the design team. You will identify and initiate investigations of medical device technologies, prototype and test solutions for device features.
You will demonstrate a working knowledge of mechanical systems. Experience in systems integration of electronics products is a plus. You will have the desire to learn from new challenges and the problem solving and communication skills to work within a diverse team. Candidates must show a hands-on passion for their work and be able to communicate their ideas and concepts both verbally and visually. Candidates must have an ability to integrate feedback and to respond quickly to changing contexts and work environments.
Activities typically includes, but limited to:
- Lead Medical Device Design Engineer teams
- Develop dynamic mechanical systems
- Design and test systems and subsystems to meet project objectives
- Select materials and component technologies to meet project objectives
- Apply technical expertise to problem solving throughout product life-cycle
- Participate in a cross functional design process, combining your skills with other disciplines, such as Risk Management and Human Factors, to develop effective designs
- Produce prototypes and perform engineering evaluations
- Collaboration with external design partners as well as external manufacturing partners
- Generate detailed design and product regulatory documentation for the DHF
- Encourage new ideas and solutions to overcome design challenges
- 5+ years’ experience working in development of medical devices or other relevant regulated industry as a Design Engineer and Team Leader or other Leading positions.
- Good Understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
- Pro/Engineer Creo experience preferred, other CAD is acceptable (Solidworks, CATIA)
- Experience in creating DHF documentation
- Good understanding for medical device technical standards; ISO, IEC, FDA guidances
- Good technical and regulatory writing skills
- Excellent leadership, organizational and interpersonal skills.
- Ability to work on teams as well as individually
- Good communication skills in English (oral and written)
Deadline for applications: 2018-05-28. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Sara Kuikka firstname.lastname@example.org 0725-487688
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.