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Sr Manufacturing Engineer (Perm)

Wilmington, MA

Posted: 07/08/2021 Industry: Engineering and Technical Job Number: 12908

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: Sr Manufacturing Engineer

Hiring Organization: Connexion Systems & Engineering

  • Duration: Perm
  • Pay rate: $100-125k
  • Job Location: Wilmington, MA
  • Job# 12908

 

Sr Manufacturing Engineer

ESSENTIAL TASKS AND DUTIES INCLUDE:

• Manufacturing Engineering and Sustaining Engineering activities associated with the production of medical systems and products.

• Provide technical expertise and support related to existing and new manufacturing processes.

• Introducing new products and processes into production, including leading Process Development and Process Validation activities related to Disposable and Hardware production.

• Creation of Production Documentation including Manufacturing, Inspection and Test Instructions and submit for approval using document change order procedures.

• Creation of Assembly and Component Drawings to support manufacturing and sustaining engineering activities.

• Selection, design, installation and maintenance of Equipment, Tooling, and fixtures used in Production.

• Support Engineering team and Production team efforts to identify opportunities to streamline production through process improvements, test improvements, and product design changes.

• Work with Production Team, Quality Assurance and Design Engineering to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, and CAPA related activities.

• Support continuous improvement project initiatives focused on improving product quality and reducing cost.

• Support Quality with activities related to quality and inspection procedures, incoming inspection methods, measurement system analysis (MSA), first article inspection (FAI), and gage repeatability and reproducibility (GR&R) activities.

• Support all facility related activities for maintaining the Production areas.

• Provide training for production and quality personnel for new and existing processes.

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

• Comply with all work safety rules and regulations.

 

BACKGROUND AND QUALIFICATIONS:

• Must have manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.

• Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans to support new and existing process and test equipment.

• Must have prior experience in the design and development of production fixtures and tooling.

• Ability to work with Solidworks, and/or Pro Engineer to create 3D models and drawings to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.

• Experience with sustaining activities and product design activities a plus.

• 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.

• 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.

• Maintain individual work area / equipment in a neat orderly manner according to standards including proper disposal of packaging waste, proper storage and use of equipment and parts, and management of documentation needed to perform duties.

• Must possess a strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.

 

EDUCATION:

• BS in Engineering plus 3-10 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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