What are the responsibilities and job description for the Principal Engineer, Metrology position at New World Medical, Inc.?
Description
JOB SUMMARY:
The Principal Engineer, Metrology is responsible for test method development, oversight of measuring equipment, metrology support, analyzing and presenting data for monitoring and other optimization activities, and ensuring compliance with regulations and standards. The Principal Engineer, Metrology provides metrology support to Quality, Production, Engineering, and R&D with a focus on new product development, continuous improvement of internal processes, metrology issues impacting daily operations, projects to enhance quality performance, and assists with internal and external audits.
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.
- Responsible for Test Method Development; this includes generation of inspection routines and programs, fixture evaluation and acceptance, generation of TMV/GRR protocols, coordination of TMV/GRR tasks, and development of final reports.
- Responsible for Measuring Equipment Oversight; this includes the evaluation, selection, procurement, and qualification of measuring equipment, and assisting in inspection related investigations, deviations, and failures.
- Collaborate with Quality, Production, Engineering, R&D, and suppliers to resolve measurement problems, perform metrology feasibility, and validations for new and existing product lines.
- Provide metrology technical support for improvement initiatives, validations, NCRs, CAPAs, SCARs, and complaint investigations.
- Maintain and analyze KPIs for monitoring of the process and/or product quality, interpret trends, and identify and initiate appropriate actions as necessary.
- Responsible for writing and updating standard operating procedures, work instructions, and forms.
- Supports audits by participating in preparation activities and addressing audit findings.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Undertake and complete assignments as designated by Quality Manager or by the department head.
- Collaborate with suppliers for alignment and development of the best metrology solutions.
Requirements
KNOWLEDGE, SKILLS, AND ABILITIES:
- Excellent understanding of regulations applicable to Medical Devices (e.g., ISO 13485, QSR, etc.).
- Strong knowledge of measurement principles, methods, and technologies.
- Advanced knowledge of measurement system analysis (TMV, GRR, Attribute Agreement Analysis, etc.)
- Technical knowledge of measuring equipment installation, qualification, calibration, and maintenance.
- Advanced programming knowledge for vision measuring systems (e.g. OGP, Keyence, etc.) and CMM (Coordinate Measuring Machine).
- Excellent understanding of blueprints, engineering drawings, and GD&T.
- Proficient in metrology-related statistical analysis software
- Proficiency in Microsoft Office Applications (MS Word, MS Excel, MS PP, MS Outlook).
- Ability to communicate in writing and orally with auditors, suppliers, supervisors, and co-workers.
- Demonstrate strong organization, planning, and prioritizing abilities; project management is a plus.
- Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas and a strong sense of urgency.
- Must be self-motivated and a good team player.
EDUCATION AND EXPERIENCE:
- 7 years of Metrology Engineering experience preferrable in the Medical Device Industry.
- Bachelor’s degree in engineering or equivalent science field, required.
- Additional professional certifications, a plus (e.g., CQE, SSGB, etc.)
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, office machinery, etc. 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 25 pounds on occasion. This may be performed with reasonable accommodation.
- Must be able to operate a computer and other office productivity devices, such as a computer printer, computer keyboard, calculator, etc.
- Must have the ability to sit, listen, speak, type, and move throughout the facility.
- Must be able to view computer screens and type for long periods of time.
This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
Salary : $130,000 - $146,000
