Senior Engineer, Metrology

Description

JOB SUMMARY: 

The Senior Engineer, Metrology is the company’s subject-matter expert for dimensional measurement. The Senior Engineer, Metrology, is responsible for ensuring the accuracy and reliability of measurements throughout our product lifecycle, with a primary focus on dimensional metrology. The Senior Engineer, Metrology, leads the development, validation, implementation, and continuous improvement of measurement systems, equipment, and processes in compliance with medical device regulations (e.g., FDA QSR, ISO 13485). The position involves direct work with advanced measurement equipment, statistical analysis, measurement software validation, and thorough documentation.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: 

• Perform all work in compliance with New World Medical’s company policy and Quality System, as well as applicable regulations and standards.

Dimensional Metrology

• Serve as the subject matter expert for dimensional measurement techniques, equipment (e.g., Coordinate Measuring Machines (CMMs), vision systems, laser scanners, hand gages), and best practices.
• Develop, optimize, and implement robust dimensional inspection methods for components, subassemblies, and finished devices.
• Troubleshoot complex measurement challenges in product design and development and production.

Measurement System Analysis (MSA) / Gage R&R

• Design, execute, analyze, and document Gage Repeatability & Reproducibility (Gage R&R) studies and other MSA activities to assess and qualify measurement systems.
• Develop clear and compliant protocols and comprehensive reports for all MSA activities.
• Interpret MSA results and implement necessary improvements to measurement systems or methods.

Measurement Software Validation

• Lead the validation of software used for automated and semi-automated inspection processes (e.g., CMM software, vision system software).
• Develop validation strategies, author validation plans, protocols (IQ/OQ/PQ or equivalent), and final reports in accordance with internal procedures and regulatory requirements.
• Execute validation protocols, ensuring data integrity and traceability.

Equipment and Process Management

• Identify, specify, and justify the procurement of new measurement equipment based on technical requirements and business needs.
• Support the calibration program by providing technical input on calibration methods, intervals, and tolerances for dimensional measurement equipment.
• Develop and maintain work instructions (WIs) and standard operating procedures (SOPs) for measurement processes.

Technical Support & Collaboration

• Collaborate with design engineering, manufacturing engineering, and quality assurance teams to ensure appropriate measurement strategies are implemented for new and existing products.
• Provide metrology support for non-conformance investigations, root cause analysis, and CAPA activities.
• Train engineers, technicians, and inspectors on proper measurement techniques and equipment operation.

Compliance

• Ensure all metrology activities, including validations and studies, are documented thoroughly and comply with the company's Quality Management System (QMS), FDA regulations (21 CFR 820), ISO 13485, and other relevant standards.
• Maintain organized and accessible records for audits and traceability.
• Participate in internal and external audits as the metrology subject matter expert.

Requirements

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong knowledge of measurement principles, methods, and technologies.
• Technical knowledge of measuring equipment installation, qualification, calibration, and maintenance.
• Proficiency in interpreting engineering drawings and applying geometric dimensioning and tolerancing (GD&T) (ASME Y14.5) principles.
• Proficiency with statistical analysis software (e.g., Minitab).
• Excellent technical writing skills for protocols, reports, and procedures.
• Proficiency in Microsoft Office applications (MS Word, MS Excel).
• Ability to communicate in writing and orally with auditors, suppliers, supervisors, and co-workers.
• Strong analytical, problem-solving, and communication skills.
• Must be able to adapt to change in the workplace and demonstrate flexibility with innovative ideas and a keen sense of urgency.

EDUCATION AND EXPERIENCE:

• 5+ years of metrology engineering experience, with a strong emphasis on dimensional measurement, preferably in the medical device industry.
•  Bachelor’s degree in mechanical, manufacturing, or industrial engineering, or a closely related technical field.
• Experience working within a regulated environment. Experience within the medical device industry specifically a plus.
• Proven experience in designing, executing, and analyzing Gage R&R / MSA studies.
• Firsthand experience programming and operating dimensional measurement equipment, e.g., CMMs, optical/vision systems, laser scanners.
• Demonstrated experience in inspection software validation (e.g., CMM, vision system software) in a regulated industry.
• Additional professional certifications, a plus (e.g., CQE, SSGB, SSBB)

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Occasionally move about inside the office and travel between office buildings to access and retrieve equipment, filing cabinets, employee offices, and office machinery. This may include but is not limited to bending and walking.
• Must be able to safely slide, lift, carry, and/or handle items weighing up to twenty-five pounds on occasion. This may be performed with reasonable accommodation.
• Must be able to operate a computer and other office productivity devices.
• Must have the ability to sit, listen, speak, type, and move throughout the facility.
• Must be able to view computer screens and type for extended periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.