Sr. Mfg Engineer
Listed on 2026-07-01
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Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer
Advanced Mfg Engineer – Direct – Lawrence, MA
Lead process development and process validation activities related disposable and hardware production.
Specify, select, design, and install of equipment, tooling, and fixtures used in production.
Develop and execute IQ/OQ/PQ protocols and reports.
Develop process capability metrics using measurement system analysis (MSA), gage repeatability and reproducibility (GR&R), and statistical process control (SPC) techniques.
Develop and define concepts and manufacturing processes for, and as an integral part of, all new product and product enhancement programs, using advanced engineering techniques such as DFM / DFA (Design for Manufacturability and Assembly) & FMEA.
Develop manufacturing planning, initial tooling requirements and costs, capability requirements, control plans, and assessments, which facilitate the definition and specification of the assembly processes.
Create production documentation including manufacturing, inspection, and test instructions and procedures and submit for approval using document change order procedures.
Author, edit, and/or contribute to project management documentation, which will include product requirement specifications, system risk analysis, and design and process FMEA's.
MUST HAVE:
- BS in Engineering plus 8+ years of experience working in an FDA/ISO regulated medical device/medical equipment industry, or equivalent education and years of experience.
- Experience in-depth process development and/or manufacturing engineering experience including the development and execution of process validation plans.
- Experience in the selection and qualification of stand alone capital equipment.
- Ability to work with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixture design and development activities.
PREFERRED:
- Experience with automated assembly machines, robotics, PLCs, injection molding, plastic joining, potting, biocompatibility, sterilization, automated inspection and/or fixture design preferred.
- Experience using Minitab or similar statistical evaluation software/tools preferred.
PLUS:
- Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
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