Research & Development
R&D Engineering Manager - Spine
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 seeking an experienced R&D Engineering Manager - Spine to join our growing team.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
REQUIREMENTS:
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.
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 seeking an experienced R&D Engineering Manager - Spine to join our growing team.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
- Manage multiple complex spine surgery systems development projects with internal and external resources from concept to launch.
- Effectively communicate with Executive Management, other departments and key stakeholders on a regular basis to ensure alignment on project baseline (scope, schedule, and budget), report on execution of project deliverables and mitigation of risks.
- Set clear expectations for direct reports and establish roles and responsibilities to manage deliverables in order to meet business commitments.
- Participate in the evaluation and assessment of products, processes or industry trends that can or have the potential to impact SpineCraft global business.
- Perform periodic reviews of progress against project plans. Ensure plans are executed appropriately within R&D department.
- Participate in the selection and hiring process of engineering talent.
- Mentor, train and supervise product development engineers and members of R&D staff.
- Promote and foster the highest standards of professionalism, ethics and compliance, transparency and actively support SpineCraft compliance program initiatives and activities.
- Review engineering designs for feasibility and accuracy.
- Oversee the transfer of design, specifications and assembly methods to the manufacturing team.
- Create and execute protocols for verification and validation testing.
- Lead design reviews to a through product development process in support of regulatory submissions and internal controls.
- Work in CAD software heavily, and think creatively.
- Participate in implants & instruments concept generation and design.
- Approve engineering drawings and specifications.
- Participate in patent application preparation, patent review and patent analysis.
- Manage the entire new product development process, and work in close co-operation with the marketing and commercial teams to help align the product launch and positioning with the development processes.
- Identify best-in-class industry product development and contract-manufacturing partners and establish business relationships.
- Continuously improve design control processes such that they genuinely drive Quality at products launch.
- Work with Quality, Manufacturing, Customer Service, Product Mangers and Sales personnel to drive continuous improvement in Cost, Quality and Reliability of devices throughout their life cycles.
- Responsible with evaluating and monitoring surgeons’ feedback.
- Assist in revising existing R&D policies, procedures and processes. Participate in writing new procedures, where appropriate.
- Ensure conformity to FDA 21 CFR Design Control and Risk Management throughout the R&D activities.
- Ensure alignment of company with other regulatory bodies.
- Embrace and promulgate Quality as a SpineCraft core value and competitive advantage.
REQUIREMENTS:
- B.S. Mechanical or Biomedical Engineering and at least 10 years’ medical devices development experience including minimum 8 years’ spine instrumentation development experience.
- M.S. Mechanical or Biomedical Engineering and at least 8 years’ medical devices development experience including minimum 6 years’ spine instrumentation development experience.
- Should have comprehensive experience in all phases of spine instrumentation products development.
- Must have the ability to prioritize and manage several projects simultaneously.
- Ability to manage and develop one to four Product Development Engineers.
- Ability to plan, conduct and direct research, development programs.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com
Senior Product Development Engineer - Spine
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:
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.
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.
- 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.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com