Synergy Spine Solutions
Senior Product Development Engineer (Denver)
Synergy Spine Solutions, Denver, Colorado, United States, 80285
The Opportunity
We are seeking a Senior Product Development Engineer with proven experience in spinal implants and instrumentation to join our team. Reporting directly to the VP of R&D, youll lead product development from concept through commercialization, working closely with surgeons, regulatory, clinical, and operations teams to bring innovative spine technologies to market.
What Youll Do Lead design and development of spinal implants and instruments from concept to launch. Translate surgeon and clinical feedback into product requirements and design solutions. Drive design verification and validation testing, including spine-specific ASTM / ISO methods. Collaborate with suppliers and manufacturers to ensure design for manufacturability and cost effectiveness. Support regulatory submissions with high-quality technical documentation. Participate in surgeon evaluations, cadaver labs, and clinical study support.
What Were Looking For Bachelors degree in Mechanical or Biomedical Engineering (Masters preferred). 7+ years of medical device product development experience, with at least 3+ years in spinal implants / instrumentation . Proficiency in CAD (SolidWorks preferred) and engineering analysis. Strong understanding of design controls, ISO 13485, ISO 14971, and FDA regulations. Hands-on, detail-oriented engineer with a track record of successful launches. Bonus : Experience with motion preservation devices, cervical spine implants, or artificial discs.
Why Join Us Be part of a small, agile team shaping the future of motion-preserving spine care. Work directly with world-class surgeons and innovators. Exposure to all aspects of product development and commercialization. Competitive compensation and benefits.
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What Youll Do Lead design and development of spinal implants and instruments from concept to launch. Translate surgeon and clinical feedback into product requirements and design solutions. Drive design verification and validation testing, including spine-specific ASTM / ISO methods. Collaborate with suppliers and manufacturers to ensure design for manufacturability and cost effectiveness. Support regulatory submissions with high-quality technical documentation. Participate in surgeon evaluations, cadaver labs, and clinical study support.
What Were Looking For Bachelors degree in Mechanical or Biomedical Engineering (Masters preferred). 7+ years of medical device product development experience, with at least 3+ years in spinal implants / instrumentation . Proficiency in CAD (SolidWorks preferred) and engineering analysis. Strong understanding of design controls, ISO 13485, ISO 14971, and FDA regulations. Hands-on, detail-oriented engineer with a track record of successful launches. Bonus : Experience with motion preservation devices, cervical spine implants, or artificial discs.
Why Join Us Be part of a small, agile team shaping the future of motion-preserving spine care. Work directly with world-class surgeons and innovators. Exposure to all aspects of product development and commercialization. Competitive compensation and benefits.
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