Project Engineer - Mechanical
About The Position
The Project Engineer will be responsible for all engineering functions required to support and advance Excelsius Cranial hardware and instrumentation. 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 person needs to have strong technical skills in mechanical engineering with relevant experience in design of mechanical systems, components, and mechanisms. The position will be hands-on and the individual must be capable of creative and systematic product development with minimal supervision. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment.
Requirements
- 3-5 years of mechanical engineering experience
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or similar program (4 years of additional design experience may suffice in lieu of a degree)
- Proficiency in CAD software (CREO Parametric preferred, Pro/E, Solidworks, etc.)
- Strong aptitude for mechanical systems, materials, and manufacturing methods
- 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 communication skills
- Motivated self-starter with good time management and organizational skills
- Proficient in the use of Microsoft Office applications
- Ability to travel up to 5% of the time
- Ability to attend surgeries and/or labs
Nice To Haves
- medical device industry experience
- Proficiency in CREO Parametric CAD software
- Knowledge of Geometric Dimensioning & Tolerancing
- Experience working in the medical device industry
- Master’s degree in Mechanical Engineering, Biomedical Engineering, or similar program
Responsibilities
- Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development
- Managing all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus' quality system and other applicable regulatory bodies.
- Supporting the creation of product requirements, specifications, and test documents
- Supporting the development of manufacturing test fixtures and documentation
- Partnering with manufacturing, internal testing, and external customers when presented with quality issues. Prioritizes work to identify the root cause and create a corrective plan that ensures timely resolution of issues
- Performing design verification and validation activities to ensure designs meet specifications
- Defining and implementing inspection procedures for incoming parts
- Assisting with product introductions through sales training, customer calls/visits, etc.
- Supporting sustaining activities including addressing complaints, CAPAs, NCMRs, etc.
- Maintaining professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
- Adhering 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
- Representing 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
