Senior Mechanical Manufacturing Engineer

Globus Medical•Audubon, PA

About The Position

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: This position is key to supporting the manufacturing of Class III implantable Neuromodulation system components for pain management. The Senior Manufacturing Engineer partners with Operations, R&D, Quality, Regulatory, and Contract Manufacturers (CMs) to develop, validate, and scale robust, efficient manufacturing processes. The role is primarily focused on manufacturing/process engineering for mechanical components and assemblies, with electrical components and test experience considered an asset.

Requirements

B.S. Mechanical Engineering, or related technical field.
7+ years of experience in manufacturing engineering, preferably in the medical device industry.
Proven hands-on experience with manufacturing process development, assembly, tooling/fixturing, and process validation.
Experience working with contract manufacturers and suppliers.
Working knowledge/ experience with FDA submission process, ISO 13485, and QSR requirements.
Strong mechanical, manufacturing, and process engineering fundamentals.
Ability to lead projects and utilize structured project management tools.
Excellent analytical, problem-solving, and technical writing skills.
Strong interpersonal and cross-functional collaboration skills.

Nice To Haves

Experience with injection molding, machining, resistance welding, laser welding a plus.
Electro-mechanical design/manufacturing and analysis skills a plus.
Experience with mechanical tolerance stack-up analysis.
Experience with Solidworks, statistical analysis tools.
Experience with PCBA processes, component obsolescence, electronics manufacturing a plus.

Responsibilities

Lead and support the manufacturing of Neuromodulation system components and assemblies, focusing on process development, optimization, and troubleshooting.
Own projects related to second sourcing, cost reductions, manufacturing transfers, tooling, fixturing, and equipment validation.
Drive and implement process improvements to increase yield, productivity, and quality, and reduce cost and manufacturing risk.
Participate in manufacturing transfer and DFM activities with device assembly manufacturing sites and suppliers.
Develop and sustain comprehensive manufacturing and product documentation (BOMs, product/component specs, MPIs, process validations, pFMEAs, CHOs/ECOs).
Collaborate and communicate effectively with contract manufacturers and suppliers, leading process validation and qualification activities (IQ/OQ/PQ/PPQ).
Act as a key resource for addressing issues encountered during manufacturing, driving root cause analysis and resolution.
Ensure compliance with Quality System regulations and actively enforce their objectives.
Travel up to 15%, including domestic and international visits to suppliers or manufacturing sites.
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 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.