Kort om tjänsten

This is a temporary consult assignment, for 1 year. Start date 180601.
Employment by Dreamwork

About the job

AstraZeneca has a long-standing reputation as being a leader in advanced Drug Delivery products. At the beginning of 2016, Pharmaceutical Technology and Development (PT&D) became an integral part of Global Operations. A global organization with 1,100+ workforce disbursed across UK, Sweden, Germany, US and China, with additional colleagues located at key manufacturing sites. We support launched and development portfolios.

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.

The role:
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
Minimum requirements:
• 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)