Senior Device Mechanical Engineer
This role offers a unique opportunity to contribute to the development and launch of innovative drug/device combination products.
We are seeking an experienced Senior Mechanical Engineer to join our Combination Product Development team. The successful candidate will be responsible for driving the mechanical design process, ensuring robust, reliable, and user-friendly products through partnerships.
The ideal candidate will have a strong background in mechanical engineering, with experience developing a range of mechanical, electromechanical and software-driven medical devices. A detailed understanding of principles and practice of Design Controls and Risk Management is also essential.
In addition to technical expertise, the successful candidate will possess excellent communication skills, with the ability to present complex information clearly to various stakeholders.
* Drive the mechanical design process, ensuring robust, reliable, and user-friendly products through partnerships.
* Oversee the development of devices for design verification and validation.
* Provide technical expertise and mentorship for the organization.
* Conduct feasibility assessment of different device solutions.
* Execute feasibility and engineering confidence tests.
* Plan the Design Outputs strategy and prepare Design Output deliverables.
* Support assembly process development for integrated combination products.
* Provide support for design verification.
* Perform root cause analysis and corrective action when required.
Key Responsibilities:
* Maintain comprehensive documentation of design processes, specifications, and test results.
* Ensure compliance with quality management systems and regulatory bodies.
* Work with software, electrical, and systems engineering teams to ensure seamless product integration.
* Stay abreast of industry trends, new technologies, and regulatory changes.
Requirements:
* M.Sc. in Mechanical Engineering, with 10+ years of experience or PhD, with 6+ years of experience.
* Demonstrated expert knowledge and experience in more than one discipline in combination product development within the pharmaceutical space.
* Experience developing a range of mechanical, electromechanical and software-driven medical devices.
* Detailed understanding of principles and practice of Design Controls and Risk Management.
Benefits:
* A diverse work environment where you can have a real impact.
* An open corporate culture.
* An attractive salary.
* An intensive onboarding process with a mentor at your side.
* Flexible work models for a healthy work-life balance.
* A corporate health management that offers comprehensive health and exercise programs.
* Company social benefits.
* A wide range of career opportunities in an international organization.
* Top-tier, attractive development opportunities.
* A strong international network.