Manufacturing Engineer

Orchid Orthopedic Solutions; Wilmington (MA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Orchid Orthopedic Solutions LLC in Massachusetts seeks a Manufacturing Engineer to develop, introduce and improve manufacturing processes for medical instruments and aerospace components. You will work on machining, moulding, assembly, finishing and packaging, ensuring capability and quality.

You will apply Lean and Six Sigma tools, collaborate with Quality Engineering, support PFMEAs and control plans, and drive continuous improvements to deliver on-time production with robust processes and

Formación

• > High-precision engineering experience in a high-precision machine shop or assembly environment.
• > Medical devices manufacturing experience preferred.
• > Proficient in blueprint reading and GD&T.
• > Experience with CAD/CAM tools such as Mastercam, SolidWorks, CREO/ProE.
• > Knowledge of CNC programming and fixture design is a plus.

Responsabilidades

• Develops and implements optimized, highly capable manufacturing processes and inspection methods.
• Recommends and implements improvements to production processes and controls using Lean and Six Sigma tools.
• Collaborates with Quality Engineering for tooling, gauging and fixtures design to ensure robust production methods.
• Supports PFMEAs and control plans.
• Estimates resource requirements, production times, and relative costs for decision-making.
• Documents and qualifies manufacturing and inspection methods.
• Assists with capital expenditure justifications.
• Provides engineering support to troubleshoot and improve on-time delivery and productivity.
• Leads Root Cause Analysis for non-conformances and CAPA.
• Leads IQ/OQ/PQ and other process validation activities.
• Leads Lean initiatives projects.

Conocimientos

High-precision machining

Lean manufacturing

Six Sigma

CAD/CAM software

GD&T

Root cause analysis

Statistical analysis

CNC programming

Technical training

fixture design

Educación

Bachelor's degree in industrial engineering

Herramientas

Mastercam

SolidWorks

CREO/ProE

Descripción del empleo

This key role will be reporting to the Engineering Manager and will have the responsibility and authority to develop, introduce and improve highly capable manufacturing processes to produce components for medical instruments and aerospace applications. Scope includes but will not be limited to machining, moulding assembly, finishing and packaging operations.

• Develops and implements optimized, highly capable, and cost-effective manufacturing processes and inspection methods, in accordance with product specifications and quality standards.
• Recommends and implements improvements to production processes, assembly methods and controls by utilizing Lean Manufacturing and Six Sigma tools.
• Collaborates with Quality Engineering for product tooling, gauging and fixtures design to ensure production methods are robust in support to achieving zero defects, reducing cost of poor quality and implement standard work.
• Supports creation of PFMEAs and control plans.
• Estimates resource requirements, production times, and relative costs to provide data for operational decision-making.
• Documents and qualifies manufacturing and inspection methods.
• Assists with justifications for capital expenditures.
• Works closely with manufacturing departments to develop, coordinate, and implement technical training for employees.
• Provides engineering support to the production department to troubleshoot and resolve technical problems to ensure On Time Delivery to customers as well as improving productivity.
• Leads Root Cause Analysis for non-conformances and Corrective Actions (CAPA).
• Leads IQ/OQ/PQ and other process validations activities.
• Leads projects for Lean Initiatives.
• Performs other related duties as assigned.

Qualification Requirements

Credentials/Experience:

• Bachelor's degree in industrial engineering, or related Engineering field or Manufacturing
• Minimum 3 years' experience in a manufacturing machining environment preferably in sheet metal fabrication or plastic environment as well as assembly using state-of-art manufacturing processes including cellular manufacturing and Demand Flow Technology or equivalent combination of education and experience.

Knowledge, Skills, and Abilities:

• Demonstrated engineering experience in a high precision machine shop and/or assembly environment.
• Experience in medical devices manufacturing is highly preferred.
• Experience and demonstrated proficiency in the use of Mastercam, SolidWorks, CREO/ProE or other CAD/CAM software.
• Knowledge of blueprint reading, and GD&T required.
• Ability to develop CNC programs desired.
• Secondary process experience (welding, polishing, electro-polish, passivation, assembly) desired.
• Experience in fixture design and tooling selection.
• Strong statistical analysis background preferred.
• Highly knowledgeable of lean techniques and six sigma tools with a Green Belt certification being a plus.
• Technical skills in manufacturing processes and methods including flow, layout, and production equipment required.
• Effective at planning, prioritizing, and organizing own work and activities.
• Experience with quality control systems and documentation.
• Excellent communication skills and self-motivated.
• Team player with entrepreneurial attitude.
• Problem solving and root cause analysis experience.

Other Requirements

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds.Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus.

Travel Requirements

N/A

Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.