Are you a senior mechanical engineer looking for a new opportunity? Are you interested in speeding up the development process of medical device products for a global pharmaceutical company? Don't hesitate, and apply today!
Job Description
The senior project manager, will support Vaccine Business Unit activities within both the Vaccine Global Product Operation (GPO) organization as well as the Manufacturing & Supply (M&S) organization
Responsibilities
The Senior Mechanical Engineer devises solutions, influences processes and strategies, and effectively communicates with the overall team. Responsibilities include, but are not limited to:
- creation of test plans
- engineering analysis data test methods, protocols, and reports,
- overseeing of test execution and root cause analysis activities.
Tasks
- The Senior Mechanical Engineer is involved in project tasks at all stages of development: they support the design of mechanical components and produce design outputs (e.g. technical drawings and specifications) of electromechanical devices, jigs, and test fixtures.
- They conduct project tasks including root-cause analysis, hypothesis testing, and Design of Experiments.
- They utilize Design for Six Sigma tools, as appropriate, to enhance the product design, ensure statistical significance of test data that is generated, and drive concept-selection in a structured and communicative way.
- The role involves working with Engineers, Technicians, and/or Operators during brainstorming and hands-on testing.
- They plan, coordinate, design, and analyse data including activities for feasibility and characterization testing, prototype testing, and V&V testing.
- They work closely with the cross-functional team: Management, Electrical Engineering, Embedded Software, System Engineering, Test Engineering, Procurement, and Quality amongst others to support successful development of technologies to meet technical, customer, and regulatory agency requirements.
- They support: risk management activities (e.g. Failure Mode and Effect Analysis); compliance assessments against medical device standards and Quality Management System requirements; creation of system/sub-system requirements, design specifications, and test methods; and ensure manufacturability and serviceability of design solutions.
- They interface with the Operations/Manufacturing Team and external suppliers during product development, enhancement, or sustaining stages to establish requirements, guide Design for Manufacturability efforts, and provide input to meet project milestones.
- They exercise sound judgment and apply systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve client products or processes.
- The Senior Mechanical Engineer will be called on to lead projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and communication of results to stakeholders.
Requirements
- Bachelor's degree in Mechanical Engineering or equivalent (e.g. Biomedical, Mechatronics, Manufacturing and Automation).
- 7-10+ years of relevant industry experience or a combination of equivalent education and experience.
- Experience in an R&D environment: full product lifecycle process is required.
- Knowledge of international standards applicable to medical devices (e.g. ISO 60601-1, EU-MDR) is highly desirable.
- Expertise in component design with the use of 3D modelling/2D drafting software (e.g. Solidworks) is essential. // open to other modelling software e.g. NX
- Expertise in assembly modelling and management (e.g. tolerance stack-up analysis) is essential.
- Experience in data acquisition and analysis through the use of statistical tools (e.g. Minitab) is highly desirable.
- Experience in leading a team of Technicians or Engineers, providing technical guidance for junior team members, and delegating of tasks and deliverables.
Additional Qualifications
- Proficient in typical office software (Microsoft Word, Excel, PowerPoint, etc.).
- Advanced knowledge of manufacturing methods and their associated capabilities and limitations.
- Ability to prioritize and multi-task, work independently with minimal supervision, or as part of a diverse team across international borders.
- Good verbal and written communication and a demonstrated capability in working collaboratively on complex projects with a diverse group of disciplines.
