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Join an innovative spine-focused medical device company seeking a Senior Product Development Engineer to play a critical role in the design, development, and continuous improvement of spinal implant and instrumentation technologies. This position offers a highly hands-on engineering environment where individuals are empowered to lead projects from concept through commercialization while collaborating directly with surgeons, manufacturing, quality, regulatory, and commercial teams. The ideal candidate is a true product development engineer with strong spine experience, a passion for design, and the desire to be a highly technical individual contributor.

Responsibilities:

• Lead product development and sustaining engineering projects for spinal implant and instrumentation systems.
• Create and maintain Design Control documentation including design inputs, outputs, risk analyses, verification, validation activities, design reviews, and project plans.
• Develop and revise engineering specifications, technical reports, protocols, drawings, and product documentation.
• Collaborate closely with Sales, Marketing, Manufacturing, Quality Assurance, and Regulatory Affairs teams throughout the product lifecycle.
• Generate and implement engineering change orders (ECOs) and product improvements.
• Investigate product complaints, identify root causes, and develop corrective action plans.
• Support product testing, design validation activities, and manufacturing process improvements.
• Write procedures and work instructions to improve product development and operational processes.
• Participate in surgeon interactions, product evaluations, cadaver labs, and training initiatives.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering discipline.
• 5+ years of medical device product development experience.
• Strong preference for spine product development experience.
• Experience with FDA regulations, Design Controls, and CFR requirements.
• Knowledge of sterile and/or non-sterile implant manufacturing processes.
• Demonstrated mechanical design expertise with strong CAD proficiency.
• Experience using SolidWorks preferred.
• Ability to create and maintain technical reports, specifications, protocols, and engineering documentation.
• Understanding of spinal procedures, biomechanics, implant performance requirements, and associated risks preferred.
• Exposure to additive manufacturing and 3D printing technologies is highly desirable.
• Familiarity with instrument sterilization processes, including steam sterilization, preferred.
• Strong project management, communication, and problem-solving skills.

Compensation:

• Base Salary: Competitive
• Annual Bonus
• 401(k)
• Comprehensive Benefits Package
• Relocation Assistance Available

The job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as needed to support the organization.

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