Mechanical Engineer - Validations Exp!!

Innovative designer and custom manufacturing company within the medical device industry looking for an experienced Manufacturing Engineer -- CHICOPEE, MA!!

This Jobot Job is hosted by: Angela Trudeau
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $70,000 - $100,000 per year

A bit about us:

We are an advanced designer and custom manufacturer of components, subassemblies, products, and packaging primarily for the medical market. We are in addition, diversified by also providing highly engineered solutions to customers in the aerospace & defense, automotive, consumer, electronics and industrial markets.

Why join us?

We offer a full benefits package, including but not limited to medical, dental, vision, life, disability, 401K with a matching contribution, paid time off, paid holidays, employee discounts and much more!

Job Details

The Manufacturing Engineer applies knowledge of continuous improvement to enhance manufacturing quality, reliability, and cost-effectiveness. May design, or work with designers to refine product designs, to increase manufacturability, and decrease costs.

Essential Duties and Responsibilities:
Applies lean manufacturing techniques to reduce medical device manufacturing waste.
Conducts time studies and adjusts production standards for medical device products as required.
Understands regulatory and industry requirements for medical device manufacturing (GMP, RoHS, REACH, etc.).
Provides direct production area support and identifies potential process improvements, efficiencies and safety issues. Continually monitors scrap rates and initiates projects to reduce scrap cost in manufacturing.
Works with team leaders and production management to review shop order variances (material and labor) and initiates projects to eliminate variances and improve actual cost performance.
Prepares work instructions to communicate the proper set-up and operation of manufacturing processes to produce products which meet customer requirements.
Trains production team members in the development and use of visual production tools to promote improvements to product quality and production efficiency.
Collects and utilizes data to make data driven decisions.
Provides reports summarizing problem solving and corrective action efforts to production teams and customers as required.
Ability to assist in the design, installation and troubleshooting of basic manufacturing equipment.
Identifies root cause of failures using statistical methods and recommends changes in designs, tolerances, or processing methods.
Prepares estimates and proposals for projects to aid in the approval of continuous improvement projects through knowledge of manufacturing capabilities and appropriate materials selection.
Submits capital projects for approval, as required.
Prepares reports summarizing information or trends related to manufacturing performance.
Works to develop a detailed understanding of customer requirements for new product launches and product sustainment. Completes all documentation required for PPAP submittal (FAI, PFMEA, SOP, etc.).
Properly drafts and submits ECRs and SICRs internally and externally to document changes to products or processes.
Supports new product transfer into production, working with our design team. Interacts with customers, account managers, manufacturing personnel, vendors and team members whenever necessary to satisfy project requirements.
Performs validations (IQ/OQ/PQ activities) on products to ensure proper performance to designated specifications. Drafts, executes, and reports validation protocols internally and externally.

Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.
Full time
Chicopee, MA 01021, US