Principal Manufacturing Engineer– Delivery System

February 27th, 2019


Primary Duties and Responsibilities:

Process and Product Development

  • Plans, directs, and coordinates manufacturing process development activities around design or processes for medical device assembly

  • Familiar with statistical methods and terminology

  • Supports new product and/or process development activities, working cross-functionally on project teams with R&D, Quality, and Regulatory

  • Works with key delivery system suppliers to provide feedback on performance and assist in implementing process changes to improve yield, reduce lead-time and cost

 

Production Management

  • Supports the manufacturing area on a daily basis to ensure production of product

  • Participates in FMEA review process, provides input, and works to mitigate identified risks

  • Investigates and implements corrective and preventive actions (CAPA)

  • Writes protocols, performs testing, and writes reports for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ)

  • Manages Preventive Maintenance System for tooling and equipment used in delivery system manufacturing

  • Oversees facility specification for the delivery system cleanroom

  • Troubleshoots design or process issues, implements improvements, and supports all other daily activities such as NCMRs, re-work, and implementation of change orders

  • Analyzes processes and creates methods for process and quality monitoring including development of and reporting of metrics

  • Supervises manufacturing personnel to assure initiatives are met in accordance to quality system

 

Technical Documentation and Training

  • Develops and maintains manufacturing documentation to define a product or process fully for use in a regulated environment

  • Writes clear and detailed test protocols and reports

  • Provides assistance to technical resources (technicians, engineers and assemblers) to assure drawings, work instructions, and methods are fully defined and validated and able to be effectively conveyed to the production staff

Manufacturing Engineering & Technician Supervision

  • Provide work direction, coaching, and guidance to manufacturing technicians and junior engineers

  • Promote employee development and foster growth of employees through:

    • Performance Management

    • Skills development

    • Continuous one-on-one feedback

    • Bi-annual appraisal of individual performance

    • Recognition and motivational techniques/tools to drive high levels of employee performance and engagement

  • Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes

 

Qualifications (Knowledge, Skills & Abilities):

Minimum

  • BS in an engineering discipline

  • 10+ yrs experience as an engineer in a regulated environment

  • 3-5 years manufacturing experience

  • Effective oral and written communication skills

  • Ability to prioritize and handle multiple tasks

  • Demonstrated problem-solving skills 

 

Preferred

  • BS in Manufacturing or Mechanical Engineering

  • 5 yrs experience as a manufacturing engineer in medical device environment

  • 1-3 years of leading and/or mentoring others, including engineers and technicians

  • Demonstrated expertise in a variety of process technologies and manufacturing environments. Preference for catheter manufacturing experience

  • Experience developing fixtures and tooling to improve manufacturing processes

  • Demonstrated leadership experience or operated in a leadership capacity (e.g.; production lead, engineering lead, supervisor) in a manufacturing environment

To submit your application, please click the following link: https://bit.ly/2Xvmpbg