Senior Project Engineer, Joints
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 Senior Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work closely with surgeons and all other functions of the company to ensure high quality and on-time product introductions.
The responsibilities of the position include, but are not limited to, the following:
- Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development
- Creating and maintaining project plans and FDA compliant Design history Files (DHF) for each project
- Managing all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
- Designing and developing instruments and implants using Pro/E software
- Conducting risk analysis and implementation of mitigating factors to ensure designs are safe for their intended use
- Partnering with in-house prototype shop and outside vendors for rapid prototyping and evaluation
- Performing design verification and validation activities to ensure designs meet specifications
- Collaborating with marketing and product managers to develop forecasts and market plans
- Assisting in the writing of regulatory applications to the FDA and other regulatory bodies
- Coordination with the operations department to setup manufacturing and/or purchasing as appropriate for each project
- Participating in product introductions through sales training, customer calls/visits, etc.
- Maintaining diligent post introduction monitoring to address incident reports and customer requests for changes
- Researching industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
- 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:
- Five plus years of mechanical design engineering experience in the medical device field, hip or knee development is strongly preferred
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or similar area of study
- Proficiency in Pro/E software or similar CAD software for design and drafting; proficiency in GD&T
- Proficiency in risk analysis techniques
- Strong verbal and written communication skills
- Proven leader of people with strong self-starting skills
- Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
- Well organized, detail oriented and team player capable of working in a deadline dictated environment
- Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
- Proficient in preparation of reports and budgets
- Proficient in Microsoft Office
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, color 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.