Senior Project Engineer, Biomaterials

NML Medical; Pennsylvania; On-site; USD 110,000 - 150,000; Full time

Job summary

Globus Medical is seeking a Senior Project Engineer, Biomaterials to lead engineering for biomaterials product lines from concept through development, FDA filings, manufacturing, and post-launch monitoring. You will collaborate with surgeons and cross-functional teams to deliver high-quality, timely introductions of innovative biomaterials.

The role requires strong hands-on biomaterials experience, in vivo testing, and proven leadership in a fast-paced medical-device environment, with a focus on

Qualifications

• Minimum five years of engineering experience, preferably in medical devices.
• MS in biomedical engineering or equivalent life sciences field.
• Hands-on biomaterials development experience (hydrogels, scaffolds, coatings, porous materials).
• Experience with in vivo testing of biomaterials in wound healing, tissue regeneration, drug delivery, or regenerative medicine.
• Strong leadership and ability to work in fast-paced environments.
• Multi-tasking, organized, and team player with attention to detail.

Responsibilities

• Capture market and surgeon feedback to define product specifications.
• Create and maintain project plans and DHF files for FDA compliance.
• Manage projects to meet timelines while adhering to quality systems and regulations.
• Design and develop biomaterials-related instruments and implants.
• Design experiments, analyze data, document results, and communicate findings.

Skills

Biomedical engineering

Project management

Leadership

Attention to detail

Communication

Teamwork

Education

MS in biomedical engineering

Tools

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, Biomaterials 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

• Obtain market feedback from surgeons and other customers to determine functional and design specifications for new product development
• Create and maintain project plans and FDA complaint Design history Files (DHF) for each project
• Manage of all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
• Design and develop instruments and implants in the areas of biomaterials, tissue engineering, and drug delivery
• Design experiments, analyze data, troubleshoot protocols, document results, and communicate findings clearly with the team
• Perform design verification and validation activities to ensure designs meet specifications
• Partner with marketing and product managers to develop forecasts and market plans
• Assist in the writing of regulatory applications to the FDA and other regulatory bodies.
• Collaborate with the operations department to setup manufacturing
• Participate in product introductions through sales training, customer calls/visits, etc.
• Maintain diligent post introduction monitoring to address and customer requests for changes
• Research market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
• Adhere 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
• Represent 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 engineering experience, preferably in the medical device field
• Master's degree in biomedical engineering, or similar life sciences area of study
• Strong hands‑on experience developing biomaterials, including hydrogels, scaffolds, coatings, porous materials, or related tissue‑interfacing materials
• Experience with in vivo testing of biomaterials in applications such as wound healing, wound dressings, tissue regeneration, bone regeneration, soft tissue repair, implantable materials, injectable materials, drug delivery systems, or regenerative medicine
• 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.