Technical Services Specialist III, Metrology

Enable Injections Inc.•Sharonville, OH

13d•Onsite

About The Position

QUALIFICATIONS Required: 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. 21CFR210, 21CFR211, 21CFR820, 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 Preferred: 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 (SolidWorks/Creo/NX) and MBD/PMI; QMS/MES (ETQ, MasterControl, TrackWise) Skills and Competencies 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 Physical Requirements 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

Requirements

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. 21CFR210, 21CFR211, 21CFR820, 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

Nice To Haves

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 (SolidWorks/Creo/NX) and MBD/PMI; QMS/MES (ETQ, MasterControl, TrackWise)

Responsibilities

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