Project Engineer - Global Implant Development
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 25%
Location: CA - San Diego
As a Project Engineer, you’ll design and develop medical devices relevant to spine surgical procedures in accordance to ISO and FDA regulations. You’ll interface with medical professionals with respect to design and development of devices, overseeing projects from inception to product launch.
- Create three dimensional computer models of devices suitable for traditional and additive manufacturing methods.
- Create engineering drawings, including assignment of dimensions and tolerances to designs.
- Create and maintain documentation relevant to design control and other applicable regulatory requirements.
- Support products at trade shows and medical meetings.
- Lead or support cadaver labs during surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc…
- Responsible for adherence to project delivery schedules and perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
- Bachelor’s degree (BSME / BSBE) or equivalent
- 5+ years engineering experience, with at least 3 years’ experience in the orthopedic medical device field
- Proficiency with CAD software (Pro/E, Creo, or SolidWorks), and Microsoft Office with a strong ability to write technical reports, business reports, and correspondence
- Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
- Effective communication skills with ability to present before groups of customers, surgeons, vendors, peers, and leadership
- 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
- Proven experience to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables.
- Ability to drive product development process with cross-functional teams (Supply Chain, Marketing, Quality, Regulatory, etc.)
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
- Experience leading projects from concept through production.
- Experience with designing for manufacturability, inspection and assembly.
- Experience with powder bed fusion additive manufacturing methods
- Proficient with design control activities and verification and validation activities with respect to medical device development.
- Solid understanding of mechanical devices specifically ones used in medical devices.
- Experience with ANSYS or similar FEA software
When applying to this role you will be completing a 15 – 20 minute assessment. Please make sure you have time to complete this assessment before initiating your application.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.