Project Engineer

NuVasive Clinical Services Monitoring, Inc.; United States; Sur place; USD 75 000 - 115 000; Plein temps

Résumé du poste

Globus Medical is seeking a dynamic Project Engineer to drive development of surgical instruments and implants from concept to commercialization. You will lead CAD design using CREO, manage DHF, and work with cross-functional teams to deliver innovative solutions while ensuring regulatory compliance.

The role involves customer engagement with surgeons for feedback, participation in product introductions, and ongoing post-market monitoring to address changes and improve outcomes.

Qualifications

• Bachelor's degree in Mechanical, Bioengineering, Biomedical Engineering, or equivalent.
• 3+ years of experience in mechanical design engineering; medical device experience preferred.
• Proficiency in CREO and/or SolidWorks for design and drafting.
• Proficiency with CAD software (CREO or SolidWorks) for design and documentation.
• Proficiency with Excel, PowerPoint, and Project for data analysis and tracking.
• Well-organized, detail-oriented, and a team player in a deadline-driven environment.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent verbal and written communication for cross-functional collaboration.
• Ability to work in both engineering and clinical environments including ORs and cadaver labs.

Responsabilités

• Lead design and development of surgical instruments and implants using CAD (CREO).
• Create and maintain project plans and FDA-compliant DHF for each project.
• Manage all aspects of assigned projects ensuring on-time completion and compliance.
• Perform design verification and validation to meet specs.
• Partner with prototype shops and external vendors for rapid prototyping.
• Assist in writing regulatory applications to FDA and others.
• Gather market feedback from surgeons to define specs for new products.
• Support product introductions through training, customer visits, and in-OR support.
• Monitor post-intro changes and ensure customer satisfaction.
• Collaborate with marketing/product managers for forecasts and market plans.
• Coordinate with operations to set up manufacturing/purchasing.
• Research industry/competitors to keep Globus at cutting edge.
• Maintain post-intro monitoring and support lifecycle management for mature products.
• Drive design updates and documentation revisions to stay compliant.
• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain on engineering changes.
• Proactively identify improvement opportunities from customer feedback and supplier input.

Connaissances

CAD design

Communication skills

Teamwork

Data analysis

Detail-oriented

Analytical thinking

Formation

Bachelors in Mechanical/Bio/Biomedical Eng

Outils

CREO

SolidWorks

Description du poste

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.

PROJECT ENGINEER

We are seeking a dynamic and detail-oriented Project Engineer to join our Product Development Trauma team. This role is pivotal in driving projects from concept through commercialization and in supporting mature products throughout their lifecycle. The ideal candidate will possess strong engineering skills and a passion for engaging with customers and cross-functional teams to deliver innovative and sustainable solutions.

Essential Functions:

Product Development:

• Lead the design and development of surgical instruments and implants using CAD software (CREO).
• Create and maintain project plans and FDA-compliant Design History Files (DHF) for each project.
• Manages 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
• Perform design verification and validation activities to ensure designs meet specifications.
• Partner with in-house prototype shops and external vendors for rapid prototyping and evaluation.
• Assist in writing regulatory applications to the FDA and other regulatory bodies.

Customer Engagement:

• Obtain market feedback from surgeons and other customers to determine functional and design specifications for new product development.
• Participate in product introductions through sales training, customer calls/visits, and support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement.
• Maintain diligent post-introduction monitoring to address customer requests for changes and ensure customer satisfaction.

Cross-Functional Collaboration:

• Collaborate with marketing and product managers to develop forecasts and market plans.
• Partner with the operations department to set up manufacturing and/or purchasing as appropriate for each project.
• Research industry and direct competitors on an ongoing basis to ensure that Globus has cutting-edge technology in all markets entered.

Product Sustaining:

• Maintains diligent post-introduction monitoring to address customer requests for changes
• Support lifecycle management of commercialized products by addressing quality issues, supply chain changes, and cost improvement initiatives.
• Drive design updates and documentation revisions as needed to maintain compliance and product performance.
• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain teams to evaluate and implement engineering changes.
• Proactively identify and communicate improvement opportunities based on customer feedback, internal testing, or supplier input.

Compliance and Conduct:

• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures 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
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
• 3+ years of experience in mechanical design engineering; medical device experience strongly preferred.
• Proficiency in CREO and/or SolidWorks software for design and drafting.
• Proficiency with CAD software (CREO or SolidWorks preferred) for mechanical design and documentation.
• Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
• Well-organized, detail-oriented, and a team player capable of working in a deadline-driven environment.
• Strong analytical and problem-solving skills with attention to detail.
• Effective verbal and written communication skills for cross-functional collaboration.
• Ability to thrive in both engineering and clinical environments, including operating rooms and cadaver labs.

Physical Demands:

• Required to sit; climb or balance; and stoop, kneel, crouch, or crawl.
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus

Our 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.