Job Description
SUMMARY
As part of R&D, apply fundamental engineering skills to design and develop new devices and platform enhancements. Additionally, provide senior leadership and mentorship to other R&D personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Contribute to the development of new and existing products
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 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
· Provide senior leadership to 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.
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.
· Experience with providing senior engineering leadership to a team
Ability to effectively lead small projects while adhering to timescales
· Experience with design and development
· Experience with FPGAs and microcontrollers
· Experience with PCB design software, preferably OrCAD or KiCAD
Experience with PCB validation protocols and reports
Experience with troubleshooting electronic systems
· 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
Excellent time-management and analytical skills
Knowledge and experience of engineering change-management processes
Preferred:
Manufacturing engineering experience (electromechanical/electronic/etc.)
EDUCATION and/or EXPERIENCE
Minimum 3-5 years of experience
Bachelor’s degree in engineering, preferably in electrical or electronics engineering
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
LANGUAGE SKILLS
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is;
May be exposed to; extreme cold and heat, fumes or airborne particles, moving mechanical parts and vibration.
Work area may include equipment such as lift trucks, pallet jacks, etc.
The noise level in the work environment can be loud. The temperature in the environment may be hot or cold.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Light to moderate physical effort required;
Must be able to regularly lift and /or move up to 30 pounds.
Frequently required to stand
Regularly required to walk
Repetitive use of hands; simple grasping, controlled grasping and fine manipulation
Specific vision abilities required by this job include; Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. Hours of work are Monday through Friday, 40 hours per week.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.
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.