Senior Product Development Engineer
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
We are looking for experienced senior/lead product development engineer to join our growing R&D team.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
- Lead a cross-functional project team (including both internal and external team members such as spine surgeons) of several new development projects.
- Direct participation in implants & instruments concept generation and design.
- Maintain and improve existing products and processes.
- Provide hands-on design, engineering, and analysis direction to other R&D engineers.
- Participate in establishing company and product strategy.
- Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, and inspection requirements and manufacturing process requirements.
- Provide engineering support to customer service, sales, marketing, regulatory and quality.
- Assure timely and effective project completion according to the project plan and budget.
- Review engineering designs for feasibility and accuracy.
- Approve engineering drawings and specifications.
- Complete and approve all Design History File documentation for assigned projects as required.
- Identify, analyze and recommend new technologies or materials for specific product applications.
- Participate in patent application preparation, patent review and patent analysis.
- Establish, develop and maintain strong working relationships with all necessary personnel to ensure smooth product design, development and commercialization.
- Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
- Assist in the resolution of manufacturing- or quality-related issues.
- Know and apply elements of the Quality System and medical device-related Federal and International standards.
EXPERIENCE & SKILL REQUIREMENTS:
- Should have comprehensive experience in all phases of spine instrumentation products development.
- Must have a solid understanding of FDA QSR, MDD and ISO-13485 principles
- Must have practical working knowledge of anatomy and physiology, especially as related to the spine, spine biomechanics, spine disorders, fundamentals of spine fusion and non-fusion surgery, mechanical test and measurement techniques and methods, manufacturing & inspection methods and processes, FDA and ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
- Must have excellent communication (verbal & written) and organizational skills. Must have demonstrated ability to work effectively in a team environment.
- Must be creative and have the ability to independently apply theoretical technical principles to product design.
- Must have the ability to apply parametric solid modeling and drafting conventions to design projects.
- Must have commanding knowledge of various software packages including Microsoft Office applications, CAD applications (nTopology and SolidWorks are required) and Engineering Simulation applications (ANSYS or similar).
- Must have the ability to prioritize and manage several projects simultaneously.
M.S. Mechanical Engineering and at least 7 years’ experience including minimum 5 years’ spine instrumentation development experience.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.