Senior Manufacturing Engineer, Surgical Instruments & NPD

Pentangle Tech Services | P5 Group; North Haven (CT); On-site; USD 85,000 - 125,000; Full time

Job summary

Pentangle Tech Services | P5 Group in North Haven, CT seeks a mid-level to senior Manufacturing Engineer for the Advanced Surgical Technologies NPD team. You will assist in development, qualification, launch and commercialization of surgical instruments and devices, working with Design and Development engineers to bring new products to market.

Responsibilities include DFA/DFM reviews, PFMEA/DFMEA, process mapping, tooling strategies in Creo/SolidWorks, line layouts and capacity analyses, FAT/QC

Qualifications

• BS Mechanical or Manufacturing Engineering required.
• 3 years for mid-level experience; 7 years for senior level.
• Proficient with Creo/SolidWorks for tooling and fixtures.
• Experience with DFA/DFM, PFMEA/DFMEA, and process validation.
• Lean/Six Sigma knowledge required.

Responsibilities

• Participate in DFA/DFM to verify manufacturability.
• Lead PFMEA, DFMEA, process mapping, and CTQ reviews.
• Create process flow charts, tooling strategies, line layouts, and capacity analyses.
• Support capital expenditure requests, schedules, and make‑buy analyses.
• Develop tooling and fixturing in Creo and SolidWorks; review OEM tooling.
• Develop FAT protocols for tooling, systems, and fixtures.
• Manage line validation activities (IQ/OQ/MRS/PQ).
• Write product evaluation protocols and analyze requests.
• Create SWI, control plans, and job safety analysis sheets.
• Contribute to Lean initiatives to stabilize lines and speed transfers.

Skills

CREO tooling review

Machine specifications

Industrial engineering basics

assembly equipment tech

IQ/OQ/PQ/MSA validations

Lean / Six Sigma

GD&T

FMEA

DFA/DFM

statistical analysis (Minitab)

control systems (PLC/vision)

Education

BS Mechanical Engineering or Mechanical Eng Tech

BS Manufacturing Engineering or Manufacturing Eng Tech

Tools

Creo

SolidWorks

Job description

Pentangle Tech Services | P5 Group in North Haven, CT seeks a mid-level to senior Manufacturing Engineer for the Advanced Surgical Technologies NPD team. You will assist in development, qualification, launch and commercialization of surgical instruments and devices, working with Design and Development engineers to bring new products to market.

Responsibilities include DFA/DFM reviews, PFMEA/DFMEA, process mapping, tooling strategies in Creo/SolidWorks, line layouts and capacity analyses, FAT/QC