Job Title: Measurement Technology Specialist
About the Role:
This is a unique opportunity to join our organization as a Measurement Technology Specialist. As part of this role, you will be responsible for implementing new measurement technologies to ensure we remain industry leaders in measurement technology.
Key Responsibilities:
- Procure, validate, set up and maintain metrology and measurement systems/equipment.
- Design and validate metrology fixtures (GRandR).
- Conduct data trend analysis to identify patterns and provide recommendations for continuous improvement.
- Document metrology system validation via protocols and reports using our standard procedures.
- Ensure all metrology equipment is correctly calibrated through auditing, managing and scheduling calibration with external vendors.
- Train metrology operators on ongoing re-fresher training and competency assessment.
- Establish and maintain documentation in line with our company standards.
- Liaise with customers and suppliers on new and existing projects.
- Maintain good internal and external communications.
- Conduct periodic audits as requested and complete necessary documentation.
Requirements:
- Must have a minimum of a degree in an engineering or science related field.
- Minimum 3 years of experience in a similar role, ideally in the Medical Device Industry; or
- Minimum 2 years of technical data review experience in cGMP laboratory; or
- Minimum 3 years' experience in cGMP pharmaceutical industry.
PREFERRED SKILLS AND QUALIFICATIONS:
- Training/certification in dimensional measurement preferred (i.e., NPL, AUKOM).
- Knowledge of programming coordinate measuring machines using software like: PC-DMIS, Calypso, Volume Graphics.
- Proficient knowledge of ISO/ASME GD&T and Transformation requirements, interpreting 2D engineering drawings and 3D models for various levels of medical device components, assemblies, and subassemblies using CAD system (e.g., SolidWorks).
- Knowledge and experience with in-house calibration procedures and calibration management software including day-to-day inspections of equipment.
- Proven experience of Measurement System Analysis (MSA) development, Minitab and statistical packages is essential.
- CT scanning knowledge would be a distinct advantage.
- Strong problem-solving and critical thinking skills to troubleshoot issues and identify root causes.
- Computer literacy required including all Microsoft Office utilities.
- Must possess good communication/interpersonal skills; must be detail-oriented, organized, flexible and able to handle multiple tasks and time-critical projects/deadlines.
- Working knowledge of ISO 9001:2000 / ISO 13485.
- Knowledge of generating validation documentation and subsequent reporting.
- Ability to motivate a team toward a common goal.
- Ability to work, lead and empower team members.
Travel Requirements: Up to 13 business days per year.
Physical Requirements: Sedentary work involves sitting most of the time, exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Additional Requirements: Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets.
- Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures.
- Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities.
- Read and interpret data, information and documents.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Ability to make independent and sound judgments.
- Observe and interpret situations, analyze and solve problems.
- Strong problem-solving and critical thinking skills to troubleshoot issues and identify root causes.
- Computer literacy required including all Microsoft Office utilities.
- Ability to successfully utilize influence to motivate a team toward a common goal.
- Drive a culture of continuous improvement and lean operations.