Sr. Process Engineer

Pentangle Tech Services | P5 Group; North Haven (CT); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

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)

Educación

BS Mechanical Engineering or Mechanical Eng Tech

BS Manufacturing Engineering or Manufacturing Eng Tech

Herramientas

Creo

SolidWorks

Descripción del empleo

Note: Seeking a Manufacturing Engineer (mid-level / Senior) for the Advanced Manufacturing Engineering team. The position will be in the New Product Development (NPD) team in the Advanced Surgical Technologies group. The Manufacturing Engineer will be responsible for assisting in the development, qualification, launch and commercialization of surgical instruments and devices. This position will work directly with the Design and development engineers in the development of new products. In parallel, the team will work on developing the commercialization strategy for the product. The commercialization strategy entails the development of a component, assembly tooling, validation, and qualification of the product.

Essential Functions

• Participate in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
• Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTQ) reviews assuring specifications are well defined and documented.
• Create and review process flow charts, assembly tooling strategies, assembly line layouts, balance tables, assembly capacity analysis, and EHS project plans.
• Participate in the development of capital expense requests, project schedules, make-buy analysis and other financial documents.
• Provide input for all assembly tooling required to support new product development activity
• Create, assemble, detail and review tooling and fixturing utilizing Creo and Solidwork’s software.
• Develop and review defining documents, RFQ packages, interact with suppliers during the quoting process, ensure supplier adherence to tooling specifications, oversee manufacture and qualification of assembly tooling.
• Develop Protocols and execute Factory Acceptance Testing (FAT) on all purchased tooling, systems and fixtures.
• Manage and support line validation / qualification activities for including IQ, OQ , MSA and PQ.
• Write testing protocols for product evaluations; oversee and analyze product evaluation requests.
• Create process documentation including SWI, Control Plans and job safety analysis sheets.
• Actively participate in Lean initiatives to stabilize production lines and reduce the time to transfer to Plant.

Minimum Requirements

Education Required

• BS Mechanical Engineering or Mechanical Engineering Technology
• BS Manufacturing Engineering or Manufacturing Engineering Technology

Minimum Experience

• 3 Years Applicable Experience for mid-Level
• 7 years Applicable Experience for Senior level

Skills / Qualifications

• Experience in CREO to review custom tooling, fixtures, gages, and components
• Review modification and development of Machine Specifications for manual, semi-automated and fully automated machines
• Basic understanding of Industrial Engineering principles including balance tables, process flow diagrams, line lay-outs, ergonomic designs, etc.
• Experience in assembly equipment technologies
• Experience with equipment and line process validations (IQ / OQ / PQ / MSA’s)
• Working knowledge of Lean Principles and/or 6 Sigma Methodology
• Working knowledge of GD&T
• Working knowledge of FMEA
• Working knowledge of DFA and DFM principles
• Familiarity with statistical analysis including capability, process control,DOE’s, control charts, etc. Minitab experience preferred, but not mandatory
• Experience or working knowledge of control systems, PLC logic, and vision systems

Competencies

• Exemplify team-work approach
• Dynamic, positive attitude
• Strong interpersonal, communication, project management and presentation skills
• Strong design, trouble-shooting, assembly tooling, and manufacturing process skills
• Strong computer skills (Microsoft Office, Project, Mini-Tab)
• Ability to mentor and provide guidance to associate team members
• Ability to work with fellow employees and suppliers on an international level.