Join Our Team

 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:

• Quality Engineer partners with Quality Assurance to create systems for compiling metrics and trending customer complaints and adverse events to proactively identify product risks and trends
• Quality Engineer provides leadership and support in the execution of complaint vigilance processes and systems.
• Quality Engineer uses Design & Quality Engineering tools for the New Product Development and Design changes to existing Products/Processes/Packages throughout the product lifecycle.
• Quality Engineer utilizes Quality Engineering principles and problem-solving skills to develop and optimize products/ processes that are aligned with the overall quality and business vision.
• Quality Engineer communicates effectively at all levels within quality cross-functionally with departments such as Regulatory, Manufacturing, and Engineering.
• Quality Engineer performs process variability studies, Risk analysis, test method variability, and establishes sampling plans.
• Quality Engineer creates protocols and executes software validations
• Quality Engineer actively participates in the planning and development of new product introductions
• Quality Engineer conducts Gage Repeatability and Reproducibility (Gage R&R), Tolerance Intervals, and Process Capability Assessments.
• Quality Engineer tracks statistical and sampling rational and performs impact assessments on product and process non-conformances.
• Quality Engineer is responsible for the quality and regulatory compliance of products manufactured by Suppliers and External Manufacturers.
• Quality Engineer works in conjunction with Manufacturing Engineering in conducting machine and process validations.
• Quality Engineer establishes inspection and test methods for assigned product lines manufactured at suppliers.
• Quality Engineer supports all company initiatives as identified by management and in support of Quality Management Systems and Environmental Health and Safety Management Systems.
• Quality Engineer ensures compliance with U.S. Food and Drug Administration regulations and the development, implementation, and effectiveness

Job Type: Full-time

Pay: $62,000.00 - $93,650.00 per year

Benefits:

• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8-hour shift

Ability to commute/relocate:

• Agoura Hills, CA 91301: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Required)
• FDA regulations: 1 year (Required)
• Industrial engineering: 1 year (Preferred)

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.

• Relevant work experience in the military or industry      will be considered in lieu of degree requirements

· 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

• Knowledge of engineering concepts and principles - Design for Manufacturability, Failure Mode and Effects Analysis, Design/Process Control Methods 
• Experience with MS Office tools such as Outlook, Excel, Word, and PowerPoint, as well as Adobe Acrobat, is required. 
• Experience with Solidworks 

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

1. Create simple to complex programs to automate mechanical/dimensional inspections for the first article, in-process, and final inspections per blueprints and/or other written specifications on designated inspection equipment such as optical computerized numerically controlled measuring systems. 
2. Calculate and set controls for inspection equipment to regulate proper and most efficient product inspection methods.
3. Start-up and observe the operation of measuring inspection equipment and programs to ensure proper operation and detect malfunctions or out-of-tolerance concerns. Adjust machine controls and program settings as required. 
4. Train employees on all automated and mechanical inspection equipment.
5. Identify and provide direction on improving inspection methods, including gages and fixtures, to expedite inspection processes.

INSPECTION

1. Perform simple to complex mechanical/dimensional inspections for the first article, in-process and final inspections per blueprints and/or other written specifications using designated inspection equipment such as optical computerized numerically controlled measuring systems. 
2. Inspect products within the estimated time requirements. 
3. Document part numbers,      lot numbers, quantities, inspection dates, and results, in log entry format, to ensure accurate product history records for each product inspection task performed.
4. Report all non-conforming product(s) to the Quality Manager. 
5. Obtain appropriate inspection gages, fixtures, attachments, accessories, and materials necessary to perform inspections.
6. Inform machine operators of any out-of-tolerance conditions or acceptability of products based on specification. 

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:

1. Strong Microsoft Office: Outlook, Excel, and Word.
2. Experience with ANSI Y14.5 Geometric Tolerance and ANSI Z 1.4 Sampling Plan. 
3. Experience with Keyence IM series or LM Series inspection system programming. 
4. Understanding of thread specifications and classifications. 
5. Advanced knowledge of a calibration program. 
6. Essential experience working with a statistical process control program.
7. Interpret and comprehend Engineering blueprints/drawings.

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.

• Experienced Tool Maker with 5+ years in a precision tool room environment.
• Proficient with all tool room machines i.e., manual lathe, mill, CNC lathe, mill, and surface grinder.
• Thorough understanding of all machinist hand and inspection tools.
• Programming experience is a must.
• Able to work from tool drawings, sketches, and verbal instructions.
• Be able to hold tolerances of +- .0005 when necessary.
• Be dependable, creative, self-motivated and able to work in a team environment.
• Work with minimum supervision.
• Good communication skills.

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