The anticipated launch date of Dr. Niznick’s new GEN5 implant system is 4Q23
The anticipated launch date of Dr. Niznick’s new GEN5 implant system is 4Q23
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Current Open Positions
Paragon Implant Mfg. is a start-up dental implant manufacturer in Calabasas, CA, founded by Dr. Gerald Niznick, a pioneer of Dental Implantology. Under the direction of Dr. Niznick, our team will develop and manufacture new dental implant systems and components with superior quality, utilizing state-of-the-art manufacturing equipment and processes, together with a talented workforce. We welcome qualified and enthusiastic people who want to be part of our team.
We are currently seeking a Design Engineer who will collaborate with other staff on the product design, research and development, marketing, and manufacturing teams to create highly functional products that meet intended user needs and regulatory requirements.
Responsibilities:
Job Type: Full-time
Pay: $62,000.00 - $93,650.00 per year
Benefits:
Schedule:
Ability to commute/relocate:
Experience:
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 essential functions. The design engineer will work in an office environment with occasional exposure to the shop floor. Appropriate PPE will be provided
Paragon Implant Mfg. is a start-up dental implant manufacturer in Calabasas, CA, founded by Dr. Gerald Niznick, a pioneer of Dental Implantology. Under the direction of Dr. Niznick, our team will develop and manufacture new dental implant systems and components with superior quality, utilizing state-of-the-art manufacturing equipment and processes, together with a talented workforce. We welcome qualified and enthusiastic people who want to be part of our team.
We are currently seeking a Design Engineer who will collaborate with other staff on the product design, research and development, marketing, and manufacturing teams to create highly functional products that meet intended user needs and regulatory requirements.
Responsibilities:
· Assesses and determines design requirements, critical features
· Determines worst-case product configurations
· Prepares tolerance studies
· Creates and/or approves engineering drawings for manufacturing and packaging
· Conducts rigorous usability tests and modifies product design based on the test results
· Creates protocols and subsequent reports for testing being performed (Biocompatibility, sterility, cleaning, shipping, labeling)
· Documents the design process and presents progress reports to all relevant team members
· Ensures adherence to applicable regulatory standards
· Responds to any question posed during regulatory audits regarding testing methods and results
· Assists with the preparation of 510k submissions and any subsequent inquiries from the FDA
· Conduct DFMEAs (Design Failure Mode and Effect Analysis)
· Conduct statistical Analysis as required
Qualifications and Experience:
· BS degree in Engineering, Math, or Physical Sciences; will consider higher education in lieu of experience and more experience in lieu of education.
· experience involving the design of complex products; application of manufacturing principles and methods including product design, process design, producibility, process qualifications/validation, product design requirements flow down to the manufacturing process
· experience with statistical methods
Work Environment: The work environment characteristics described here are representative of those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For example, the design engineer will work in an office environment with occasional exposure to the shop floor. Appropriate PPE will be provided.
Job Type: Full-time
Pay: $65,000.00 - $150,000.00
JOB SUMMARY: Create programs to automate product inspection processes on computerized inspection equipment (Keyence LM & Vision System SeeBrez) to verify dimension, tolerance, functionality, configuration, aesthetics, surface finish, plating, and material per inspection methods outlined in First Article, Online, and Final inspection guidelines. Coordinate with Tooling personnel on the design and configuration of new gages and fixtures to expedite inspection processes. Evaluate current inspection methods and trends to identify process improvements. Responsibilities include inspection of, in-process, outsourced, purchased, and modified products following cGMP compliance for Class II medical devices.
ESSENTIAL DUTIES:
PROGRAMMING / PROCESS IMPROVEMENT
INSPECTION
MINIMUM REQUIREMENTS: 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 essential functions.
EDUCATION and/or EXPERIENCE: High School diploma required; some college or technical training preferred. A minimum of eight (8) years of quality assurance mechanical inspection experience is required, or a combination of education and/or experience.
LANGUAGE SKILLS: Ability to write reports and business correspondence. Ability to effectively present information and respond to questions and communicate clearly while maintaining a high level of professionalism.
REASONING ABILITY: Able to perform product traceability tasks by reviewing the product history, researching and investigating all steps and processes about the specific product to ensure the effectiveness of the Quality System.
Ability to apply common sense understanding to carry out detailed written and/or oral instructions. Being able to assess large amounts of information and data quickly is very important. The ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound, intuitive judgment is crucial to reaching favorable decisions. Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to apply sound business judgment, are important.
OTHER SKILLS and ABILITIES:
PHYSICAL DEMANDS: The physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel objects. For example, the employee frequently is required to sit, stand, walk, reach with hands and arms, and talk or hear and will occasionally be required to bend, stoop, kneel, and climb stairs.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee occasionally works near moving mechanical parts. The noise level in the work environment is usually moderate to loud.
Job Type: Full-time
Pay: $80,000.00 - $135,000.00
JOB SUMMARY: Assist in the manufacturing of dental implants through the use of mills, lathes, and grinders.
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 essential functions. Must be able to lift up to 50 pounds, climb, and operate the equipment – radial arm drill, conventional lathe, mill, band saw, grinders, welding machine, and various hand tools.
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 essential functions. General machine shop. Exposed to noise, grease, coolants, metal shavings, grinder dust, and industrial machinery (moving parts, etc.).
Job Type: Full-time
Compensation: DOE
Job Type: Full-time
Pay: $45,000.00 - $80,000.00
If you're interested in one of our open positions, start by applying here and attaching your resume.
If you're interested in applying for a position that is not listed above, please download the application form below, fill it out and submit your application to
We are looking forward to your submissions.
Paragon-job-application (pdf)
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