Sr Project Engineer, Development
Globus Medical
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 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 spine 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 developmentCreating and maintaining project plans and FDA complaint Design history Files (DHF) for each projectManaging all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodiesDesigning and developing instruments and implants using Creo softwarePartnering with in-house prototype shop and outside vendors for rapid prototyping and evaluationPerforming design verification and validation activities to ensure designs meet specificationsCollaborating with marketing and product managers to develop forecasts and market plansAssisting in the writing of regulatory applications to the FDA and other regulatory bodiesPartnering with the operations department to setup manufacturing and/or purchasing as appropriate for each projectParticipating in product introductions through sales training, customer calls/visits, etc.Maintaining diligent post introduction monitoring to address and customer requests for changesResearching industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets enteredAdhering 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 roleRepresenting 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 GlobusReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.In order to be qualified for this role, you must possess the following:Minimum five years of mechanical design engineering experience, preferably in the medical device fieldBachelor's degree in Mechanical Engineering or similar area of studyProficiency in Creo software for design and drafting requiredProven leader of people with strong self-starting skillsAbility to work in fast paced environment; Multi-tasking abilities required for successful job completionWell organized, detail oriented and team player capable of working in a deadline dictated environmentAbility to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peersProficient in preparation of reports and budgetsProficient in Microsoft OfficeOur Values:Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.Equal Employment Opportunity:Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.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.SummaryLocation: Audubon, PAType: Full time
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