- 10 years experience in medical device field in Product Development
- Bachelor’s Degree required Masters preferred
- Well organized, detail oriented, and team player capable of working in a deadline dictated environment
- Excellent oral and written communication skills
- MUST HAVE in-depth knowledge of SPINE IMPLANTS (spine cages and pedicle screw fixation systems)
- Ability to design products on Day 1
- Detailed knowledge of the entire development/commercialization process from conception to regulatory approval and commercialization.
- Needs to have hands-on experience.
This individual must demonstrate strong leadership, project planning and execution skills including successful budget management. This individual must be able to build strong cross-functional relationships both with internal and external business partners. Excellent written and verbal communication skills and strong presentation abilities are required. This individual must be willing and able to work within a Cadaver Lab and/or Operating Room as occasional business/training needs require. Solid knowledge of Windows, MS Word, Excel, Outlook, PowerPoint, Project and Pro-e or equivalent Design software.
The ability to effectively work on multiple tasks is required. The ability to apply theoretical technical principles to product design as typically gained through a 4-year technical degree with limited supervision is required. The ability to use written or oral format to effectively communicate critical design/project information to customers is required. The ability to apply FDA QSR/ISO9000 design control regulations to projects which result in meeting FDA/Company guidelines and policies is required. Knowledge and ability to apply DEX (Design Excellence) is preferred.
A minimum of a Bachelor’s Degree is required, preferably in Mechanical, Bio-Mechanical Engineering or another related discipline. An advanced degree (MS) is preferred. A Minimum of 4 years of Project Management experience in a professional setting is required. Black Belt training and/or certification is desired.
Additional Description
Company is focused on the development of a broad range of products including spinal implants, orthopedic navigation, combination products and cardiovascular products.
The Senior Project Engineer, will conceptualize, designs and develop medical device products to support product introduction and company expansion into new markets.
Strong technical aptitude, in-depth knowledge of the development of spinal implants and a desire to learn is a must. This individual will lead multifunction development teams and interface with surgeons and company executives on a daily basis. Responsible for the conceptualization of novel products, prototyping and testing making use of core proprietary technology.
Comprehensive understanding of design controls including the development of design inputs and outputs and the verification and validation of medical device products for commercial release. Needs to be able to analyze multiple options and present a detailed analysis to assist in the decision making process and development of a multi-generational product plan.
Comfort working with little supervision, the ability to quickly adapt to change and versatility among different product platforms is a requirement.
Location: Atlanta GA