Lead Metrologist/CMM Programmer

Summary of Function:

The Lead Metrologist supports Engineering activities at Medbio, including Product/Process Qualification/Validations, engineering studies, product development reviews. Will be responsible for training Quality Metrologists, Technicians, Inspectors and Operators in metrology practices. Will assist in identifying new metrology equipment needs and leading improvement teams to improve the process of measurement, data storage, and reporting. Will support product and process investigations when needed. Will support other areas of the organization, while adhering to relevant ISO and cGMP, and FDA regulatory requirements.

Major Duties and Responsibilities:

Leadership:

· Maintains Project Schedule - Updates the schedule daily and communicates in summary so others can determine what the overall status of the project is.

· Training - Can effectively demonstrate and communicate processes, technology, methods, tools, and tasks that result in advancing the necessary skills of self and other technical staff.

· Metrology Inventory Control - Maintains inventory to make sure all critical tools are available and accessible to reduce/eliminate delays in project launch and/or manufacturability.

· Technical Writing - Can effectively create metrology reports, procedures, technical documents and other communication media that is, complete, clear, concise, and coherent.

· Develop and Report Department Metrics - Helps with creating and maintaining the appropriate measures that contribute to the organizational goals and commitments to its stakeholders.

· Prioritize Work Assignments - Determines the order in which tasks are performed according to their relative importance daily.

· Identifies Knowledge Gaps - Identifies the discrepancy or lack of information, skill, and understanding that an individual, team, or organization has, compared to what they need to know to perform effectively or achieve desired outcomes.

· Leads Improvement Teams - Can identify areas for improvement and lead small improvement teams in an organized and documented fashion.

· Develop and Maintain Procedures as needed - Can develop procedures, work instructions, department specifications related to Metrology and inspection in a clear and concise format.

Metrology:

· Operate Precision Equipment - Measure the size of a processed part when checking and marking it to check if it is up to standard by use of two- and three-dimensional precision measuring equipment such as a Coordinate Measuring Machine, Scanning equipment, and advance X-ray devises, as well as hand tools like calipers, micrometers, height gages, pin gages, and other measuring gages.

· Performs Gage Repeatability and Reproducibility Studies - Operate devices, machinery, and equipment designed for scientific measurement. Scientific equipment consists of specialized measuring instruments refined to facilitate the acquisition of data. Validates the measurement system through planning, executing, analyzing, and reporting MSA's.

· Performs Engineering Studies - Understands requests to conduct engineering studies as specified.

· Mold Qualification Process - Fully understands and can execute the Mold Qualification process from project submission forms to final reports.

· Advanced Equipment Programming - Gains the necessary knowledge to interpret drawings, innovate and create advanced programming techniques. Interpret and explain the content and purpose of the program logically.

· Advanced Equipment Program Problem Solving - Investigates, identifies, and deploys solutions to eliminate or repair programming issues to support manufacturing.

· SPC Control Chart Applications - Has the knowledge to decipher appropriate SPC control chart applications. Can read charts to help determine possible root causes and identify variation in processes to make necessary improvements. Can train others on control chart theories.

· Interprets basic Statistics (Cp-Cpk, Pp-Ppk, normality, etc) - Generates the necessary reports and can determine acceptability using basic statistics (Ppk, normality, standard deviations, range, outliers, etc.).

· Support Fixture Design (3D printing) - Has the knowledge to use CAD and SolidWorks to support 3D modeling, fixture creation, programming needs. Has the knowledge to design and create 3D printed fixtures to support manufacturing and measurement needs.

· Study the Relationship Between Data & Quantities - Advanced Planning. Use numbers and symbols to research the link between quantities, magnitudes, and forms. Interpret engineering drawings and GD&T applications to determine best methods and meet design and measurement intent.

· Calibration OOT Investigation and Impact (CAPA) - Analyzes and interprets Calibration CoA reports to determine impact to product as a result non-conforming condition.

· Advanced Fixture and Design - Has the ability to gain the necessary knowledge to work with other departments and venders to develop robust fixtures.

· Perform Scientific Research - Gain, correct, or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations.

· Develops Test & Measuring Equipment - Develop and understand new measuring equipment for quantitatively measurable properties such as length, area, volume, speed, energy, force, and others.

· Laboratory Design and Control - Supports development and changes to metrology labs to make them operate effectively and efficiently while supporting all equipment requirements and specifications. Manages the control of the metrology labs from housekeeping, temperature and humidity, airborne particle counts.

· Interprets Advanced Statistics (Hypothesis, correlation, regression, T-test, etc.) - Generates the necessary reports to determine cause and effect and other relationships between data sets using advanced statistical tools and can interpret and explain results logically.

· Develops Calibration Procedures - Develop test procedures for instrument performance testing.

· Performs other tasks assigned by Quality Management.

The Lead Metrologist reports directly to the Quality Manager. Management, Supervisors, Team Leaders, and Technical Staffing can look to the Lead Metrologist for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the Lead Metrologist to assist with blueprint interpretation, potential fixturing designs, and in problem resolution both internally and externally. The Lead Metrologist will work closely with the Quality metrologists, technicians, and Inspectors as well as manufacturing to develop and improve metrology-related practices.

Experience and/or Educational Requirements:

· Two-year degree or equivalent in years' experience in a Quality-related field is preferred

· Good understanding and involved in plastic injection molding is preferred

· Five years or more experience in CMM and/or other software-operated metrology equipment

· Experience in a medical device or pharmaceutical manufacturing environment is preferred

· Solid understanding of ISO and FDA regulations and cGMP requirements and cleanroom ethics

· Good computer skills (Microsoft Office), databases

· Excellent blueprint reading skills with strength in GD&T principles

· Very strong written/verbal communication, leadership, interpersonal and motivational skills

· Self-motivation and ability to manage the Lead Metrologist’s portion of complex projects with important deadlines

Physical Requirements:

Must be able to work a standard 40-hour work week with occasional overtime, including weekends as a possibility. Sitting and/or standing for extended periods of time as well as some walking within the facility. Must have 20/20 vision with or without corrective lenses and be able to distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. Must be able to lift and carry various items up to 50 pounds.

Job Type: Full-time

Pay: $35.00 - $38.00 per hour

Benefits:

• 401(k)
• 401(k) 4% Match
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Overtime
• Weekends as needed

Work Location: In person

Salary : $35 - $38