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Advanced Manufacturing Engineer

Lawrence , MA

Posted: 06/13/2022 Industry: Engineering and Technical Job Number: 14503

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

 

Title Advanced Manufacturing Engineer

Hiring Organization: Connexion Systems & Engineering

  • Duration: Perm
  • Pay rate: $ 125-150k
  • Job Location: Lawrence, MA
  • Job# 14503

 

Advanced Manufacturing Engineer

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

· Advanced Manufacturing Engineering activities associated with the design, development, and introduction of assembly processes used in the next generation of Organ Care System Products.

· Introduce new processes into production, including leading Process Development and Process Validation activities related to 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.

· Collaborate with external and internal NPI design teams to ensure new processes are capable and transferred to manufacturing smoothly.

· Serve as strong team player, supporting and assisting supervisor and colleagues when necessary.

· Comply with all work safety rules and regulations.

· REQUIREMENTS:

· Must have 5 years' manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.

· Must have prior in-depth Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans.

· Experience with automated assembly machines, robotics, PLCs, injection molding, plastic joining, potting, biocompatibility, sterilization, automated inspection and/or fixture design preferred.

· Must have demonstrated 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.

· Must have effective analytical and decision making skills. Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.

· Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.

· Must be detailed oriented with strong organizational skills and interpersonal skills with outstanding ability to communicate clearly and effectively.

· Must have ability to identify, prioritize, and resolve issues as they arise with minimal supervision.

EDUCATION:

· 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. ?

 

 

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