Sr Project Engineer, Development

NML Medical; Pennsylvania; On-site; USD 110,000 - 140,000; Full time

Job summary

Globus Medical is seeking a Senior Project Engineer to oversee engineering functions across product lines, from concept to FDA approvals and post-launch monitoring. You will work with spine surgeons and cross-functional teams to ensure quality and on-time product introductions.

Required five years in mechanical design engineering, a mechanical engineering degree, and Creo proficiency. Strong leadership, multitasking, and communication skills are essential to navigate regulatory requirements and

Qualifications

• Minimum five years of mechanical design engineering experience, preferably in the medical device field.
• Bachelor's degree in Mechanical Engineering or similar area of study.
• Proficiency in Creo software for design and drafting.
• 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.

Responsibilities

• Obtaining market feedback from surgeons and customers to determine functional and design specifications for new product development.
• Creating and maintaining project plans and FDA complaint DHF for each project.
• Managing all aspects of assigned projects to ensure timely completion while complying with quality systems and regulatory bodies.
• Designing and developing instruments and implants using Creo software.
• Partnering with prototype shops and 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 writing regulatory applications to the FDA and other bodies.
• Partnering with operations to setup manufacturing and/or purchasing for each project.
• Participating in product introductions through training and customer visits.
• Maintaining post introduction monitoring to address customer requests for changes.
• Researching industry and competitors to ensure cutting edge technology.

Skills

Mechanical design engineering

Leadership

multitasking

Attention to detail

Team player

Report writing

Communication

Microsoft Office

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 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.

• 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.

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 field
• 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

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.