Job Title [Engineering Associate]
Reports to: Engineering Manager
Position Type: Full Time- Non-exempt
- 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.
- 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.
- Backup/ team coverage of other functions
- Other projects and duties as assigned by to other departments