Mechanical Engineer 2
About the position Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. About Veranex: Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human-centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. About This Role: Veranex has an exciting opportunity to join the Mechanical Engineering Team. You will be part of a team working to improve lives globally through healthcare innovation. You will participate in mechanical design and development activities through all phases of the medical project development process, from the initial design effort through testing and validation, and final manufacturing transfer. This role reports to the Director of Mechanical Engineering and collaborates with Product Development & Engineering teams globally. The ideal candidate should be an innovative, creative, and well-organized self-starter, a good problem solver, collaborative, and passionate about enhancing patient care and advancing the healthcare industry. Experience with medical device development or a similar regulated industry is preferred. As a consultant, they should be comfortable working with clients as a trusted partner, managing risk-based decisions in the interest of project success. They should possess good conceptual and analytical skills, along with the ability to solve complex technical problems. Be able to effectively manage multiple tasks and projects and resolve a wide range of problems in creative ways.
Responsibilities
- Execute the design and development of complex electro-mechanical medical devices and equipment.
- Participate in a variety of manufacturing
processes, including injection molding of plastics, machining methods, rapid prototyping techniques, etc.
- Develop detailed computer-aided design (CAD) packages to include 3D data and 2D drawings.
- Maintain day-to-day communication with program managers and all appropriate program team members.
- Research and procure sample components and develop prototypes.
- Develop and execute prototype testing plans and protocols.
- Ensure compliance with medical device regulations and standards.
- Functions as a mechanical engineering team member on product development programs.
- Utilize understanding of product development
- Train to and understand overall medical device industry Food & Drug Administration (FDA), Quality System Regulation (QSR) and International Organization for Standardization (ISO) regulations
Requirements
- BS Mechanical Engineering
- 2+ years relevant work experience
- Working knowledge of medical product development
- Strong knowledge in Microsoft Office and SolidWorks
- Excellent written and verbal communication skills.
- Excellent attention to detail
- Multi-tasking and time management skills with the ability to prioritize tasks.
Nice-to-haves
- Experience with medical device development or a similar regulated industry is preferred.
- As a consultant, they should be comfortable working with clients as a trusted partner, managing risk-based decisions in the interest of project success.
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