Principal Mechanical Engineer

Globus Medical•Audubon, PA

22h

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: The Principal Mechanical Engineer will design, develop, and deliver high-reliability mechanical components and assemblies for Class III implantable neuromodulation systems and associated external accessories used in spinal cord injury repair. This role ensures mechanical integrity, patient safety, and compliance with medical device regulations across the full product lifecycle. This engineer will also serve as a technical influencer, shaping mechanical architecture decisions, directing cross-functional design activities, and guiding teams toward robust, scalable engineering solutions.

Requirements

Bachelor’s degree in Mechanical, Biomedical, or related Engineering field (MS or PhD preferred).
8+ years of experience in medical device design or regulated industry, with at least 4 years focused on implantable Class III devices.
Expertise in CAD (SolidWorks or similar), tolerance stack-ups, FEA, and GD&T.
Proven experience with biocompatible materials, hermetic device design, and implantable reliability engineering.
Strong electro-mechanical design/manufacturing and analysis skills.
Experience identifying and managing contract manufacturers.
Familiarity with manufacturing methods like welding, injection molding, and precision machining.
Strong understanding of medical device regulatory and quality standards (21 CFR 820, ISO 13485, ISO 14708, ISO 10993).
Demonstrated ability to lead by influence, drive complex programs, and thrive in a dynamic R&D environment.
Requires the ability to travel approximately 10% of the time throughout the United States and internationally
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.

Responsibilities

Product Design & Architecture Lead mechanical design of implantable pulse generators (IPGs), leads, surgical tools, and accessories.
Establish product requirements and specifications
Research, understand and design to relevant product specific standards
Build and test preliminary ideas using rapid prototyping tools to evaluate design concepts and iterate toward final designs
Apply design for excellence (DFX) principles including design for manufacturability (DFM) and design for assembly (DFA) to balance functionality, usability, and manufacturability.
Own discussions with physicians and other clinicians on product design and development activities and gather feedback on product prototypes
Materials & Processes Develop and refine assembly processes involving hermetic sealing, laser welding, overmolding, and adhesive bonding.
Collaborate with suppliers and internal teams to review designs and provide feedback on tooling, tolerances, material selection and assembly processes
Work directly with suppliers to design custom components/fixtures, review drawings, and perform process validations
Testing & Reliability Define and execute verification test protocols, methods and reports to ensure products meet design requirements
Lead root cause analysis and implement design mitigations for mechanical failure modes.
Contribute to the development of custom test methods, test fixtures, and test method validation.
Documentation & Compliance Generate engineering documentation in support of design controls (e.g., DHF, FMEA, test protocols, reports).
Participate in design reviews and risk analyses in compliance with FDA, ISO 13485, and IEC 60601 standards.
Responsible for ECOs and other documentation in compliance with FDA guidelines and ISO requirements
Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, RIFs, MPIs, LHRs), and other Quality System requirements.
Clinical & Cross-Functional Collaboration Gather and integrate feedback from physicians, patients, and clinical staff to inform iterative product design.
Collaborate with systems engineering, electronics, software, and clinical teams to ensure robust product integration.
Communicate effectively across functions and present findings to senior management.
Conduct risk management documentation including hazard analysis and failure modes and effect analysis (FMEA) to identify and mitigate design and process risks
Leadership & Mentoring Provide technical direction to cross-functional development teams.
Mentor engineers and support team growth through knowledge sharing and design leadership.
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.