- Contribute to the development of new and existing products and processes
- Design and develop products from proof of concept through product launch
- Work in a cross functional team, collaborating with engineers, QA/RA specialists, marketing personnel, and manufacturing employees for product generation
- Create and maintain technical drawings for product components and assemblies
- Design and develop manufacturing processes and fixtures for product assembly
- Design and develop inspection procedures for accurate quality control of components and assemblies
- Create process validation protocols and reports, conducting hands-on testing to gather applicable data
- Identify potential design concerns throughout the development process, by conducting technical reviews of designs and documentation
- Create and maintain documentation for product specific DHF (design history files) and DMR (device master records) throughout the R&D process and over the life of the product
- Ensure the compliance of the design controls procedure, by working closely with regulatory personnel throughout new product development and design changes
- Identify and implement improvements to established products and processes, by working closely with regulatory and manufacturing personnel
- Assist other R&D personnel with analytical solutions and problem-solving
- Manage engineering change requests related to new product releases and current product design changes
- Provide technical input to marketing and regulatory personnel regarding products within your work cell
- Oversee technical issues with component suppliers
- Create project schedules in the form of Gantt charts and action item lists
- Provide accurate completion date and remaining work estimates for Project Managers
- Communicate on the progress of projects
- Other duties may be assigned.
- Experience with design and development
- Experience with drafting/CAD software, preferably SolidWorks
- Experience with the creation and understanding of technical drawings and GD&T tolerancing
- Proficiency in Microsoft Office applications, including Word and Excel
- Great attention to detail, especially proofreading of documentation prior to submittal
- Strong organizational skills
- Ability to multi-task on different projects, while maintaining high quality performance
- Strong communication skills, both written and spoken
- Ability to work cross-functionally with a team, including engineering, regulatory, marketing, and manufacturing personnel
- Ability to problem solve and think outside of the box
- The desire to be hands-on and involved through the entire process
- Proficient at technical problem-solving
- Proficient with development tools
- Proficient in technical writing
- Knowledge and experience of engineering change-management processes
- Ability to effectively lead small projects while adhering to timescales
- Manufacturing engineering experience (electromechanical/electronic/etc.)
- Experience with the development and implementation of new products
- Excellent time-management and analytical skills
- Minimum 2 years of experience (relevant internships/co-ops will be considered in place of industry experience)
- Bachelor's degree in engineering, preferably in mechanical engineering
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Mechanical Design Engineer - Chesterfield, United States - Katalyst Surgical "a ZEISS Company
Description
Job Description
Job DescriptionSUMMARY
As part of R&D, apply fundamental engineering skills to design and develop neurosurgical devices and platform enhancements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Coming from humble beginnings, Katalyst's history dates back to 1985, where founder Gregg Scheller created the Advanced Surgical Products brand with just 2 partners. The first ASP model was introduced later that year and was the invention of the first disposable light pipe for Retina surgical endoillumination. This first prototype was produced in 1985 on a kitchen table. A few years later, in 1990, the manufacturer produced over 180,000 lightpipes on an annual basis. This supplied the entirety of the industry, including the Storz, Alcon, and Grieshaber brands.
Today, when Retina Surgeons all over the world think of the Katalyst brand, they think of surgical innovation — and rightly so. Katalyst now produces many different models that deliver strong surgical performance and offer a variety of unique performance and ergonomic design features that distinguish the Katalyst brand.
Company Description
Today, Katalyst is the face of Retina surgical instrument development. However, many do not know about the brand's modest early days. Learn more about the Katalyst history below, including what inspired the famous Katalyst logo, along with some of Katalyst Scheller's favorite Developments throughout the years.\r\r
Coming from humble beginnings, Katalyst's history dates back to 1985, where founder Gregg Scheller created the Advanced Surgical Products brand with just 2 partners. The first ASP model was introduced later that year and was the invention of the first disposable light pipe for Retina surgical endoillumination. This first prototype was produced in 1985 on a kitchen table. A few years later, in 1990, the manufacturer produced over 180,000 lightpipes on an annual basis. This supplied the entirety of the industry, including the Storz, Alcon, and Grieshaber brands.\r
\r
Today, when Retina Surgeons all over the world think of the Katalyst brand, they think of surgical innovation — and rightly so. Katalyst now produces many different models that deliver strong surgical performance and offer a variety of unique performance and ergonomic design features that distinguish the Katalyst brand.
