Manufacturing Process Engineer
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Manufacturing Process 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.
The responsibilities of the position include, but are not limited to, the following:
- Analyzing new product specifications, translating design inputs into manufacturing processes to establish efficient production rates and reliability of finished product
- Being a technical resource for the initiation and implementation of cost improvement plans on new and existing projects
- Developing and releasing 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
- Implementing and completing with vendors as well as other process validations as needed
- Collaborating and partnering with product design, product management, quality and operations
- Participating in design reviews and manufacturing meetings to evaluate design and to help identify alternative design solutions
- Participating in verification and validation efforts to identify and mitigate areas of risk
- Performing sustaining activities on released product to address life cycle issues, continuous improvement, reliability, and cost reductions
- Overseeing Vendor process risk management during design to production transfer
- Utilizing 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
- 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
- Adhering 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
- Representing 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
In order to be qualified for this role, you must possess the following:
- Minimum of 4 years of mechanical or development engineering experience – preferably in the Medical Device field; Bachelor’s Degree in Engineering
- Experience with ISO requirements, FDA Regulations, and cGMP’s
- Experiencing interacting or running engineering functions within a manufacturing environment
- 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
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.