Manufacturing Engineer

globusmedical; Methuen (MA); On-site; USD 78,000 - 110,000; Full time

Job summary

Globus Medical is seeking a Manufacturing Engineer to join our dynamic operations team in Massachusetts. You will provide technical support to Manufacturing to identify root causes and resolve issues, and you will help develop and release test fixtures and assembly aids for our medical robotic and navigation products.

The role emphasizes hands-on problem solving, documentation, and collaboration with QA, Product Development, and other teams to ensure regulatory compliance and smooth NPI, while

Qualifications

• Bachelor's degree in Engineering with 2-5 years of relevant experience; Master’s with 0-3 years is also acceptable.
• Experience in Medical Device field and/or Robotics.
• Familiarity with ISO requirements, FDA Regulations, and cGMPs.
• Excellent written and verbal communication and ability to travel up to 5%.

Responsibilities

• Provide technical support to Manufacturing to identify root cause and resolve issues in a timely manner.
• Develop and maintain procedures and equipment used for manufacturing medical robotic and navigation products.
• Develop and release test fixtures/assembly aids for use in manufacturing.
• Generate change orders to update documentation and BOMs for released product.
• Draft SOPs, Operation & Maintenance Procedures, protocols, reports, and process validations.
• Interface with QA/QC to ensure products and processes meet regulatory requirements.
• Collaborate with Product Development for smooth NPI and design changes.
• Work with cross-functional teams on lifecycle issues, improvements, and cost reductions.

Skills

Communication skills

Teamwork

Data analysis

KPIs

Regulatory knowledge

Problem solving

Education

Bachelor's Degree in Engineering

Master's Degree (optional)

Tools

Windows

Microsoft Office

Outlook

Teams

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 :

As part of the operations team, the Manufacturing Engineer needs to have strong technical skills, be hands-on, and creative with minimal supervision. The job requires a team player with the ability to function well in a challenging, fast paced environment. This person must be enthusiastic, positive, even tempered and have strong skills in areas of communication, dependability, interpersonal relationships, flexibility and maturity.

Essential Functions :

• Provide technical support to Manufacturing to identify root cause and resolved issues in a timely manner.
• Develop and maintain procedures and equipment used for manufacturing medical robotic and navigation products.
• Develop and release test fixtures/assembly aides for use in manufacturing.
• Generate change orders to update documentation and BOMs for released product.
• Demonstrate effective writing skills for drafting SOP's, Operation & Maintanence Procedures, protocols, reports, process validations and other manufacturing related documentation.
• Interface with Quality Assurance/Quality Control to assure products and processes comply with all regulatory requirements for products and manufacturing processes.
• Work with Product Development teams to achieve a smooth new product introduction (NPI) and implement design changes to existing products.
• Work with a cross-functional sustaining team to address life cycle issues, continuous improvement, reliability, and cost reductions for existing products.
• 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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications :

• Bachelor's Degree in Engineering with 2-5 years of relevant experience or a Master's Degree with 0-3 years of relevant experience
• Familiarity with a variety of industry concepts, practices, and procedures.
• Ability to work independently and as a key contributor in small teams.
• Excellent oral, written, and graphical communication skills.
• Working knowledge of Windows, Microsoft Office, Outlook, and Teams.
• Ability to travel up to 5% of the time.
• Experience in Medical Device field and/or Robotics.
• Experience with data analysis and KPIs.
• Familiarity with ISO requirements, FDA Regulations, and cGMP's all required regulations.

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, sexua