Manufacturing Process Engineer

Globus Medical Inc.•Audubon, PA

70d

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary: The Sourcing Engineer will work within the Product Development process to achieve cost, feature, and performance requirements by increasing manufacturing reliability, accelerating design through minimized iterations, and reducing production complexity.

Requirements

Bachelor's Degree in Engineering; or minimum of 4 years of mechanical or development engineering experience - preferably in the Medical Device field
Experience with ISO requirements, FDA Regulations, and cGMP's
Familiar with a variety of industry concepts, practices, and procedures.
Ability to work independently and as a key contributor in small teams
Excellent oral, written, and graphical communication skills
Proficient in Windows, Microsoft Office
Ability to travel up to 10% of the time

Responsibilities

Analyzes new product specifications, translating design inputs into manufacturing processes to establish efficient production rates and reliability of finished product
Be a technical resource for the initiation and implementation of cost improvement plans on new and existing projects
Develop and release test fixtures/assembly aides for use in manufacturing
Overseeing, coordinating, and at times performing design verification and validation activities, to include Part Process Performance Qualifications
Implement and complete with vendors as well as other process validations as needed
Collaborating and partnering with product design, product management, quality and operations
Participate in design reviews and manufacturing meetings to evaluate design and to help identify alternative design solutions
Participate in verification and validation efforts to identify and mitigate areas of risk
Perform sustaining activities on released product to address life cycle issues, continuous improvement, reliability, and cost reductions
Oversee Vendor process risk management during design to production transfer
Ability to use engineering design software such as Pro/E, Unigraphics, NX, Solidworks, etc Understanding of design intent and the ability to understand which features of the print can and cannot be changed in order to retain the original intent.
Experience interacting or running engineering functions within a manufacturing environment
Possesses effective writing skills for drafting SOP's, protocols, reports, process validations and other manufacturing related documentation
Understanding of Process FMEAs and Process Validations (IQ, OQ, PQ)
Understanding of project plans and the launch life cycle
Understanding of FDA compliance around validations, gauging, Device History Records in design and in manufacturing
Understanding of RCCA, CAPA's, DFMEA, PFMEA, and SCAR
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus.