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Senior Mechanical Engineer
2 months ago
X4 Life Sciences are looking for a Senior Mechanical Engineer with over 5 years of experience in medical device development, product design, and mechanical engineering to join one of out Medical Device consultancy clients.
In This Role, You Will:
- Lead engineering teams, advise clients, and manage the planning, design, and execution of projects, ensuring timely delivery of all deliverables.
- Communicate effectively with clients regarding deliverables, design reviews, and deadlines.
- Develop mechanical concepts for packaging strategies, mechanisms, and parts, balancing function, form, and budget requirements.
- Perform concept development, prototyping, testing, and analysis in collaboration with industrial designers and human factors engineers.
- Create 3D CAD models of parts and assemblies using SolidWorks or similar software, optimizing designs for manufacturability and assembly.
- Plan and conduct formal verification testing, including developing test methods, validating them, analyzing data, and designing experiments.
- Document design history file activities, including planning, system requirements, risk management, hazard analysis, design inputs and outputs, and test plans.
- Stay updated on project progress, identifying and resolving any emerging issues with team members.
- Occasionally travel to client sites, typically within a one-hour commute from our location.
Qualifications:
- Bachelor's degree in mechanical engineering or a related field.
- Experience in new product development, mechanical design, and engineering processes from concept to production.
- Knowledge of FDA design controls (21CFR 820) and standards such as ISO 13485 and 14971.
- Familiarity with sterilization, biocompatibility, sterile packaging, shelf-life, and validation testing.
- Strong teamwork, interpersonal, and communication skills, with the ability to perform independently and collaboratively at a high level.
- Ability to thrive in a fast-paced environment, manage projects and deadlines, and adapt to shifting priorities.
Apply to express your interest in the position or reach me directly at l.denham@x4lifesciences.com
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