Technician 3 NPD Metrology, Orthopedics

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Business Enablement/Support

All Job Posting Locations:

Warsaw, Indiana, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at  https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Technician 3 NPD Metrology, Orthopedics

JOB SUMMARY

The Metrology Technician is responsible for the support for the inspection strategy associated with all metrology equipment by compiling data and preparing reports on findings, conducting scheduled calibration and maintenance on test equipment, establishing maintenance and calibration schedule for test equipment based on manufacturers recommendations and maintains equipment records.Recommends and implements revisions, corrections and changes to test equipment, procedures and

methods.

• Under supervision, this individual is responsible for supporting the quality processes associated with product metrology, procedures, and controls to ensure that all work is processed in accordance with established company procedures and worldwide regulations and standards.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Interprets drawings featuring Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5 to identify product inspection requirements.
• Writes and edits programs for programmable inspection equipment utilized in inspection/manufacturing (e.g. PC-DMIS, COSMO & CALYPSO, etc.).
• Serves as technical expert for Metrology inspection.
• Facilitates, encourages and coordinates continuous improvement with respect to inspection activities.
• Set-up data collection parameters for inspection measurements where required.
• Installation of Metrology inspection assets as to follow local validation lifecycle.
• Develops inspection strategies to meet business needs.
• Development of new inspection techniques as required.
• Development of standard platforms where applicable (vision systems, contact/non-contact inspection systems.
• Support Quality Engineering in developing method of “gauge” evaluation to consider, calibration frequencies, gauge life, fit for purpose, etc.
• Generates the inspection report per the customer requirements.
• Performs 1st Article inspection of newly developed product (when applicable). Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 7
• Support Quality Engineering in the development of inspection fixturing to ensure minimum
• measurement error during inspection.
• Inspect complex machined fixtures, and parts using advanced measuring and layout instruments and equipment.
• Participates in design reviews on cross-functional teams to ensure that conformance to specifications, Design for Inspection (inspectability), reliability, and quality system objectives are met.
• Assist engineers with qualification and validation of new or changed tooling or parts.
• Prepare detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications.
• Work from written or verbal instructions, detailed engineering drawings, and 3D models.
• Support Quality Engineering in writing of work instructions for inspection techniques relating to standard platforms for associates.
• Support Quality Engineering in writing of instructions for gauge usage or set-up instructions.
• Support Quality Engineering in writing of Gauge R&R/test method validation protocol and engineering reports.
• Writing of equipment installation protocols and engineering reports for Metrology.
• Development of validation approach in conjunction with QA for all Metrology inspection platforms.
• Train, as needed, QA/Manufacturing personnel to execute measurement method/equipment.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

A High School Diploma and a minimum of 2–3 years of experience in a Metrology, Inspection, or related area. Experience working in an ISO 13485 or another highly regulated industry is preferred. Knowledge of 21 CFR 820, 21 CFR 11, FDA, and international regulatory requirements associated with the medical device industry is an asset.

The candidate must meet the following essential job requirements:

• Working knowledge of writing and editing CMM programs, such as PC-DMIS, COSMOS, or CALYPSO.
• Working knowledge of the setup and operation of inspection equipment.
• Working knowledge of Gauge R&R and test method validation.
• Working knowledge of metrology methods and technologies.
• Working knowledge of reading and interpreting engineering drawings, including the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5.
• Foundational knowledge of mathematical applications, including Algebra, Geometry, and Trigonometry.
• Ability to understand and interpret spatial and 3-D concepts.
• Working knowledge of Microsoft Word and Excel.
• Good interpersonal and communication skills.
• Knowledge of mechanical inspection methods and tools used to determine product acceptance.
• Ability and willingness to learn and apply new technologies within metrology.
• Experience with Process Excellence or Continuous Process Improvement is preferred.
• Familiarity with Lean and 5S techniques is preferred.
• Experience with laser scanning techniques and other non-contact inspection technologies is preferred.
• Working knowledge of GMP/QSR requirements.
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment is preferred.
• Familiarity with statistical tools and analysis software is preferred.
• Familiarity with risk analysis is preferred.
• Ability to work independently on routine tasks with strong attention to detail.
• Strong organizational and multitasking skills, with the ability to work effectively against deadlines.
• Strong oral and written English communication skills are highly preferred.
• Ability to work cross-functionally, build effective working relationships, prioritize work, communicate challenges constructively, and solve problems is highly preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via  https://www.jnj.com/contact-us/careers.  Internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

 

 

Preferred Skills:

Agility Jumps, Backup Management, Change Control Management, Communication, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Process Oriented, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Report Writing, Research and Development, Robotic Automation