Senior Project Engineer, Mechatronics

NML Medical; Lower Providence Township (PA); On-site; USD 110,000 - 170,000; Full time

Job summary

Globus Medical seeks a Senior Project Engineer, Mechatronics to lead end-to-end product development in the medical device field. You will design instruments and implants in Creo, manage DHFs, work with suppliers, and ensure on-time, compliant product introductions.

Responsibilities include design verification/validation, regulatory submissions, and collaboration with marketing, operations, and surgeons to deliver innovative, high-quality solutions.

Qualifications

• Bachelor's degree in Mechanical Engineering or similar field.
• Creo proficiency for design/drafting.
• Minimum five years of mechanical design engineering experience, preferably in medical devices/robotics.

Responsibilities

• Gather market feedback from surgeons and customers to define specs for new products.
• Create and maintain Design History Files (DHF) for each project and manage project plans.
• Lead project teams to meet deadlines while complying with quality systems and regulations.
• Design instruments/implants using Creo; collaborate with prototype shops and vendors.
• Perform design verification/validation to ensure specs are met.
• Work with marketing/product managers on forecasts and market plans.
• Assist in FDA/regulatory applications; set up manufacturing/purchasing as needed.
• Support product introductions and post-introduction monitoring.

Skills

Leadership

Self-starting

Team player

Detail oriented

Multi-tasking

Organized

Education

Bachelor's degree in Mechanical Engineering

Tools

Creo

Microsoft Office

Job description

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, Mechatronics 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.

Essential Functions:

• 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 complaint 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 Creo software
• 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
• Partnering 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 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
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions

Qualifications:

• Minimum five years of mechanical design engineering experience, preferably in the medical device and/or robotics field
• Manufacturing experience in the Endovascular space strongly preferred
• Bachelor's degree in Mechanical Engineering or similar area of study
• Proficiency in Creo software for design and drafting required
• 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

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity 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.

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.