Position Summary:
The Sr. Mechanical Engineer will join the R&D team responsible for developing intraoperative neuromonitoring system used in complex spinal and cranial surgeries. This role includes both sustaining our current products in the field and leading mechanical design and development for next-generation NPI projects from concept through commercialization. The engineer will collaborate closely with cross-functional partners including Regulatory, Quality, Supply Chain, and Manufacturing, to manage the product development process, timelines, and deliverables, ensuring designs are safe, effective, and compliant for clinical use. Responsibilities include conducting feasibility studies to validate design intent and maintaining thorough documentation throughout all phases of R&D.
Essential Functions:
- Leads mechanical design & development for NPI and Sustaining projects, coordinates and manages ME timelines
- Creates advanced mechanical designs using CAD and/or SolidWorks software or in-house rapid prototyping equipment suitable for traditional, novel, and additive manufacturing methods while applying design for manufacturing principles
- Coordinates with suppliers and supply chain teams to manage the production and commercialization process, and drives the cost optimization
- Creates and maintains documentation relevant to design control and other applicable regulatory requirements
- Works with surgeons and OR staff to understand user needs
- Creates and maintains requirements, design specifications, Risk Management & FMEAs
- Participates in project planning, design and phase review, as well as audits and assists with mechanical designs and design history file documentation creation and approval
- Oversees manufacturing partners to ensure complete, accurate and timely delivery of clinical product
- Leads or supports cadaver labs during surgeon design team evaluations and surgeon education events.
- 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.
Qualifications:
- Typically requires a minimum of 5-7 years of related experience
- Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
- Proficiency with CAD and SolidWorks software (Pro/E, Creo, or SolidWorks), and Microsoft Office with a strong ability to write technical reports, business reports, and correspondence
- Proficiency and knowledge in applying concepts of algebra, geometry, trigonometry, calculus, geometric tolerances, and tolerance analysis in addition to ability to solve and interpret problems, collect data, establish facts, and draw valid conclusions
- Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
- Strong understanding of manufacturing processes and design for manufacturing
- Strong ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13585 & IEC 60601
- Previous medical device experience; spine or orthopedics preferred
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
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.
