Technical Services Specialist III, Metrology

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Description:

Location: Onsite

Status Type: Full Time

• Associate degree in mechanical/manufacturing/industrial engineering or engineering technology, metrology, or related field; or equivalent hands‑on experience
• 5 years of metrology / measurement method development experience in medical device, pharmaceutical, or highly regulated precision manufacturing
• Advanced GD&T proficiency and complex datum scheme interpretation (ASME Y14.5)
• Hands‑on CMM programming/operation (PC‑DMIS, ZEISS CALYPSO, or equivalent) plus one optical/vision platform
• Strong knowledge of MSA (Gage R&R), SPC, capability analysis (Cp/Cpk), and statistical problem solving
• Experience working within a regulated environment with standardized quality systems (e.g. 21
  
  CFR
  210, 21
  
  CFR
  211, 21
  
  CFR
  820, ISO 13485); experience with industry standards (e.g. ISO 17025)
• Traceability and investigation of out‑of‑tolerance impacts (risk‑based assessment to lots/batches)
• Robust experience in preparing technical reports to support method, equipment, and system qualification or validation. Specifically, IOQ and MSA protocols and reports

• Experience with non‑contact metrology (laser/white light scanning, CT) and complex form analysis (roundness, cylindricity, flatness)
• Exposure to cleanroom measurement practices and environmental controls for sensitive materials/surfaces
• Data automation skills (exporting CMM data to QMS/MES/ERP, basic scripting for report generation)
• Audit support experience (FDA, Notified Body, customer) and ability to professionally articulate information under review and scrutiny
• CMM:
  Hexagon/Leitz (PC‑DMIS), ZEISS (CALYPSO), Mitutoyo (MCOSMOS), Renishaw probing
• Optical/Scanning: OGP, Keyence, Nikon, ZEISS O-Inspect; GOM/ATOS, Faro/Hexagon arms
• Software:
  Minitab, Q‑DAS, or equivalent SPC; CAD (Solid Works/Creo/NX) and MBD/PMI; QMS/MES (ETQ, Master Control, Track Wise)

• Designs and documents methods that are auditable, validated, and risk‑justified
• Establishes repeatable, reproducible methods with quantified measurement uncertainty
• Communicates complex metrology insights to design, manufacturing, and quality audiences
• Identifies challenge areas and uses statistical thinking and structured root cause tools to drive solutions
• Proactive in closing gaps, standardizing methods, and maintaining calibration compliance

• Work in Quality and Manufacturing departments when required
• Ability to remain sedentary for extended periods of time
• Light work that includes moving objects up to 40 pounds
• Position requires being physically present on the premises during regular company hours or as approved by management
• Occasional off‑shift/weekend support for validation builds and urgent investigations
• Ability to travel approximately 20% as needed

• Measurement strategy and execution
• Deduct GR&R studies to improve measurement efforts
• Develop alternate methods to improve efficiency and quality of data for new and existing components
• Working with supplier inspection methods to ensure data collection accuracy
• Translate drawings, 3D models, and GD&T (ASME Y14.5) into risk‑based measurement plans aligned with CTQs and ISO 14971 risk controls
• Program, set up, and operate CMMs (e.g., PC‑DMIS, ZEISS CALYPSO), vision/optical systems, and non‑contact scanners; establish fixturing and environmental controls to minimize uncertainty
• Develop and maintain validated inspection methods and work instructions with clear measurement uncertainty and acceptance criteria
• Analyze measurement data to ensure accuracy and consistency, and assist with technical reports (e.g. component qualification plan / report) to support ongoing and new component management
• Provide technical support and training on measurement methods and related activities to Quality Control
• Perform measurement data collection to support validations, qualifications, investigations, and incoming inspections as needed
• Ensure all work is in compliance with applicable standards and consistent with the expectations of a regulated medical device manufacturing environment
• Other duties as assigned