Job Title [Engineering Associate]

Reports to: Engineering Manager

Position Type: Full Time- Non-exempt

Primary Responsibilities

  • Actively participate and contributes an innovative perspective on new product development for both product design ad process developement
  • Assist the implementation of continuous improvement activities. Applies lean manufacturing and six-sigma techniques to eliminate waste, reduce lead times and improve product quality
  • Assist product transfers from one location to another. May be internal moves as well as global suppliers.
  • Assist with process and equipment validations/qualifications (IQ, OQ, PQ)
  • Prepare and implement manufacturing process work instructions and operating procedures
  • Maintain data integrity throughout the systems and reporting tools
  • Liaise and support cross-functional teams (Suppliers, QA/RA, Planning, Warehouse, Sales, Marketing and Finance) to ensure the company meets performance targets

Expertise: Knowledge & Skills

  • Demonstrated analytical skills, superior organizational and multi-tasking skills
  • Knowledge of FDA QSR/ISO guidance and QMS requirements
  • Knowledge of project management tools and methods
  • Knowledge of blueprint development, blueprint reading and GD&T
  • Knowledge of lean manufacturing principles and six-Sigma problem solving techniques
  • Excellent interpersonal abilities, ability to get along with diverse personalities and develop strong business relationships with vendors and associates; tactful, mature and flexible. Must have good reasoning abilities, organization awareness, sound judgement.
  • High energy level and comfort performing multiple projects along with day-to-day activities
  • Results-orientated with a tireless work ethic.

Required/Preferred Education and Experience

  • Pursuing or Completed Bachelor’s degree in Biomedical, Mechanical, Industrial or Manufacturing Engineering or Associates Degree with significant experience
  • Preferred pursing Lean Green Belt or higher or Certified Manufacturing Engineer certification (CMfgE)
  • Experience and proficiency with CAD software, SolidWorks required
  • Experience and proficiency in Microsoft products and ERP Systems.
  • Excellent understanding of computer-based tools and how to apply them to improve business processes, reporting and analytics.
  • Ability to understand meaningful KPIs with validated data.

Supervisory Responsibility

  • This position has no supervisory responsibilities.

Physical Demands and Work Environment

  • This position requires up to 10% travel.
  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
  • While performing the duties of this job, the employee is regularly required to talk and hear.

Other Duties

  • Backup/ team coverage of other functions
  • Other projects and duties as assigned by to other departments