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Senior Manufacturing Engineer - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 5/10/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    5/10/2019

Job Description

Job Function Summary:

Work cross functionally between manufacturing, maintenance, quality engineering, supplier quality engineering, process engineering, regulatory affairs, and product development to sustain and improve the manufacturing process for medical devices in a fast paced highly regulated environment.

Job Functions

  • Production support including scrap reduction, equipment downtime reduction, and increased throughput for a high volume low mix production department within a controlled environment (clean room)
  • Trouble shooting problems daily including equipment problems, process issues, and supplier component related problems.
  • Review department data and SPC data to identify areas for opportunity and proactively solve problems with a data driven approach.
  • MRB support including leading non-conformance investigations and corrective actions.
  • CAPA support as needed.
  • Work with internal design/equipment engineers and/or outside equipment vendors to build knowledge base and establish relationships for existing equipment on the production floor.
  • Work with Validation and Quality engineers to develop validation plan(s) for new equipment / processes.
  • Maintain compliance to Quality System and regulations for existing processes and equipment.
  • May be required to participate in equipment acceptance testing (EAT), installation qualification (IQ), process development, operation qualification (OQ), and Test Method Validations (TMV) activities related to making changes to exiting validated process / equipment.
  • Write and execute protocols and reports.
  • Work closely with Process Engineers and Product Development to support new processes and equipment that have been recently released into production.
  • Responsible for change orders (ECO/DCO’s) required to release and/or update controlled documents.
  • Responsible for manufacturing specifications, equipment history files, BOM’s/Routings, and procedures including manufacturing procedures, preventative maintenance, and calibration procedures.
  • Agile approvals to support department.
  • Handle customer complaints and failure analysis of field returns.
  • Provide direction & mentoring to junior engineers & engineering technicians as needed. 
  • Assists in special projects as needed. 
  • Contributes to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities: 

  • Experience with plastics (ABS) including mold design, mold defects, and solutions for molding related issues.
  • Experience with vibration and ultrasonic welding of plastic components.
  • Experience with inkjet, leak test systems, and Cognex vision systems.
  • Well organized with an attention to detail.
  • Strong problem solving / troubleshooting skills.
  • Experience with highly automated equipment is desired.
  • Electro-mechanical experience including experience with Festo, SMC, Swadgelok, FasTest, Allen Bradley, and Parker.
  • Able to read equipment drawings both mechanical and electrical.
  • Experience with process control & statistical analysis techniques.
  • A good understanding of Lean methods is preferred.
  • Excellent communication skills with the ability to present technical information and prepare written reports.
  • Strong writing skills are required.
  • Strong computer skills including MS Office Suite (Word, Excel, Power Point) and Minitab.
  • Able to work independently and in a cross functional team environment.
  • Experience with mentoring / providing direction to junior engineering staff.
  • Project management experience is preferred.
  • Experience in a medical device environment or other regulated industry is preferred.  
  • Clean room experience preferred.
  • GDP experience is preferred.

Minimum Requirements:  

  • Bachelors or Master’s Degree in Engineering, or equivalent work experience.
  • Minimum of 5 years of process engineering, manufacturing engineering, or other related experience.  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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