Sustaining Engineer

Globus Medical Audubon , PA 19407

Posted 2 weeks ago

The Sustaining Engineer assures that all Globus products and processes meet the highest regulatory and internal standards by rigorously applying engineering principals across multiple different elements of the business. Working primarily with Product Development, the Sustaining Engineer will ensure the smooth operation of existing product lines as well as guide the introduction of all new products with respect to the company's quality system.

Job Responsibilities

  • Review inspection processes and issues. Create and provide guidance on inspection sheets and gauging.

  • Attend on or off site vendor meetings when required to evaluate and discuss product and manufacturing quality.

  • Implement and complete Part Process Performance Qualifications with vendors as well as other process validations as needed.

  • Quarterly analysis of all field complaints to identify trends in cause of returns. Recommend changes to design based on complaint investigation.

  • Quarterly review of vendor NCMRs to identify trends in reasoning for non-conformance.

  • Lead the investigation of reoccurring product problems. Work with Product Development team to identify and manage corrective actions resulting from problem investigation including CAPA's, FMEA, and SCAR initiation and review.

  • 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.

  • Maintain product DHF's and ensure risk management, line extension, design review, and other associated documentation are included and up to date.

  • Review and conduct post market surveillance activities as required.

  • 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.

  • Other duties as assigned or required.

Qualifications

Bachelor's degree in Mechanical or Process Engineering required. Three to five years of quality engineering experience preferably in the medical device field

  • Experience developing quality standards, methods, work instructions and procedures for the inspection of manufactured products

  • Able to interpret drawings and specifications to develop and apply quality tests and inspection methods

  • Demonstrated ability to use analysis tools to analyze and resolve technical/process issues varying from basic to very complex

  • Proficient in preparation of reports and trend analyses

  • Well organized, detail oriented and a self-starter capable of working in a deadline dictated environment

  • Working knowledge of Microsoft Office

  • Ability to travel

  • Will be required to attend labs

Physical Demands

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, color vision, peripheral vision, depth perception and ability to adjust focus.

Other Duties

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.

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.


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Sustaining Engineer

Globus Medical