Manufacturing Engineer I

The Manufacturing Engineer is responsible for improving existing manufacturing processes and methods as well as assisting in the transition of new products from development phase to manufacturing. The incumbent will also assist the Director, Operations, in improving production control systems, standard operating procedures, safety, quality control and training.

This position is not eligible for relocation or sponsorship.

EOE M/F/D/V

Job Duties:

* Improve manufacturing processes and methods for cost- reduction, quality improvement and efficiency.

* Prepare and present plans for the above and coordinate deployment including training of team members.

* Assist Director of Operations in improving production control systems, standard operating procedures, safety, quality control and training.

* Assist Director of Operations with short and long-term planning and budgeting.

* Prepare and maintain detailed layouts of processes and related equipment.

* Coordinate the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.

* Confer with management, engineering and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.

* Confer with sales, planning and design engineering staff concerning product design and tooling to ensure efficient production methods and quality results.

* Design, develop and test and/or source and cost-justify various tools, machinery and equipment for recommended manufacturing methods.

* Confer with vendors to determine product specifications and arrange for purchase of machinery and equipment according to specifications and quality standards.

* Apply statistical methods and perform product/process analysis for cost reduction, quality improvement, and improved efficiency.

* Represent manufacturing/engineering on cross-functional teams.

* Work with a cross-functional team to develop manufacturing processes, select and qualify vendors.

* Validate, scale-up and optimize production processes to world- class standards.

* Troubleshoot and critically analyze production outcomes and data. Identify, plan and implement process changes.

* Develop and implement validation activities for equipment, process and products.

* Interact with vendors to ensure smooth flow of critical components for Manufacturing.

* Manage the validation activities for equipment, process, and products.

* Achieve production goals on time and within cost projections.

* Adhere to quality system requirements as defined in the Company’s Quality Management Program and controlled documents and safety system.

* Perform all other duties as necessary and assigned.

Job Requirements:

(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

* Bachelor’s Degree in Mechanical, Industrial, Electrical or Bio-medical Engineering is required. Advanced Degree is a plus.

* Minimum of 1 year experience in manufacturing engineering is required.

* Experience with process and equipment validation is required.

* Medical device, bioengineering or aerospace domain experience is preferred.

* Understanding of production requirements, ISO and QSR regulations is necessary.

* Knowledge of computers, machining and assembly practices, tools and fixturing is essential.

* Understanding of production planning, scheduling and CIP procedures are preferred.

* Ability to work under pressure with multiple priorities is necessary.

* Understanding of Statistical Process Control (SPC) is desired.

* Understanding of Demand Flow Technology (DFT) process is essential.

* Understanding of equipment and process validation is desired.

* Knowledge of engineering and manufacturing processes is preferred.

* Must have good verbal and written communication skills.

* Ability to read, write, and comprehend English required.

* Must have high level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint.

* Visio skills is desired.

* Must have proven record of consistently following through on commitments.

* Ability to maintain and communicate realistic schedules and meets or beats deadlines is essential.

* Must have service oriented approach, flexible and proactive towards changing needs.

* Must be exceptionally team focused and actively contribute to a positive and innovative work environment.

* Ability to work precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality is necessary.

* Must demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.