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Location: Onsite
Status Type: Full Time
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
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
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