Spinal Elements
Base pay range
$115,000.00/yr - $135,000.00/yr About Spinal Elements
Spinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at http://www.spinalelements.com/. About the role
As a Project Engineer at Spinal Elements, you will be responsible for leading projects, designing standard and complex spinal devices, working with Key Opinion Leaders (KOL), and performing verification, validation, and improvement of designs, processes, and systems. This role will play a key part in cross-functional project execution including concept, launch, and post market surveillance ensuring technical accuracy, regulatory compliance, and timely delivery of innovative spine solutions. This role will also provide engineering support for existing projects when needed. Primary Responsibilities
Leads product development projects from concept, launch, and post market surveillance ensuring compliance with internal processes and regulatory standards. Drives creation of product requirements, design inputs, design outputs, verification testing, design validation, and technical specifications in alignment with surgeon and market needs. Oversees all engineering activities related to product development, including CAD modeling utilizing SolidWorks, prototyping, testing, and documentation. Coordinates and leads design reviews, risk assessments, and design verification/validation activities. Owns and maintains the Design History File (DHF) for assigned projects. Develops quality control procedures and inspection methods. Creates, reviews, and approves engineering change orders (COs) and design documentation. Serves as the primary point of contact for engineering on cross-functional teams. Manages project timelines, resource planning, and technical deliverables while escalating risks proactively. Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify the cause. Resolves and assesses a wide range of issues in creative ways and suggests variations in approach. Provides technical input to marketing counterparts on the development of collateral marketing materials. Provides technical expertise to marketing and sales team as to design intent. Provides technical expertise to regulatory affairs team to support FDA submissions. Contributes to long-term product and technology roadmaps. Other duties as assigned. What Makes You Successful (KSA’s)
Strong project management, organizational skills, and design. Proficient in medical device design controls, verification/validation, and risk management. Excellent communication and team leadership skills. Ability to balance technical depth with program-level decision-making. What You’ll Get (Benefits & Perks)
A full and comprehensive benefits program including medical, dental, vision, short term and long-term disability, flexible spending accounts, and more Wellness program and Employee Assistance Program (EAP) Retirement savings plan (401k) with 4% company match Educational reimbursement program Travel Assistance Program and Legal Services 10 paid company holidays and 1 floating holiday 15 days PTO Experience and Education
Bachelor’s degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics with 6-8 years related work experience or equivalent. Master’s degree (MA/MS) in a directly related field preferred; candidates may also have completed some postgraduate work. Requires 3+ years of product development experience in implantable orthopedic medical devices, ideally with a focus on spine. Prior experience in leading development projects is required. Spine or orthopedic experience is preferred. Work Authorization
US Work Authorization required Physical Demands
While performing the duties of this job, the employee is regularly required to stand, walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus Travel
Limited travel required; dependent on responsibilities and project load up to 15% of the time. Compensation
Pay range: $115,000 - $135,000 annual base salary. Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Please do not forward resumes to the TA/HR team or Spinal Elements employees. Spinal Elements is not responsible for any fees related to unsolicited resumes/applications.
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$115,000.00/yr - $135,000.00/yr About Spinal Elements
Spinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at http://www.spinalelements.com/. About the role
As a Project Engineer at Spinal Elements, you will be responsible for leading projects, designing standard and complex spinal devices, working with Key Opinion Leaders (KOL), and performing verification, validation, and improvement of designs, processes, and systems. This role will play a key part in cross-functional project execution including concept, launch, and post market surveillance ensuring technical accuracy, regulatory compliance, and timely delivery of innovative spine solutions. This role will also provide engineering support for existing projects when needed. Primary Responsibilities
Leads product development projects from concept, launch, and post market surveillance ensuring compliance with internal processes and regulatory standards. Drives creation of product requirements, design inputs, design outputs, verification testing, design validation, and technical specifications in alignment with surgeon and market needs. Oversees all engineering activities related to product development, including CAD modeling utilizing SolidWorks, prototyping, testing, and documentation. Coordinates and leads design reviews, risk assessments, and design verification/validation activities. Owns and maintains the Design History File (DHF) for assigned projects. Develops quality control procedures and inspection methods. Creates, reviews, and approves engineering change orders (COs) and design documentation. Serves as the primary point of contact for engineering on cross-functional teams. Manages project timelines, resource planning, and technical deliverables while escalating risks proactively. Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify the cause. Resolves and assesses a wide range of issues in creative ways and suggests variations in approach. Provides technical input to marketing counterparts on the development of collateral marketing materials. Provides technical expertise to marketing and sales team as to design intent. Provides technical expertise to regulatory affairs team to support FDA submissions. Contributes to long-term product and technology roadmaps. Other duties as assigned. What Makes You Successful (KSA’s)
Strong project management, organizational skills, and design. Proficient in medical device design controls, verification/validation, and risk management. Excellent communication and team leadership skills. Ability to balance technical depth with program-level decision-making. What You’ll Get (Benefits & Perks)
A full and comprehensive benefits program including medical, dental, vision, short term and long-term disability, flexible spending accounts, and more Wellness program and Employee Assistance Program (EAP) Retirement savings plan (401k) with 4% company match Educational reimbursement program Travel Assistance Program and Legal Services 10 paid company holidays and 1 floating holiday 15 days PTO Experience and Education
Bachelor’s degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics with 6-8 years related work experience or equivalent. Master’s degree (MA/MS) in a directly related field preferred; candidates may also have completed some postgraduate work. Requires 3+ years of product development experience in implantable orthopedic medical devices, ideally with a focus on spine. Prior experience in leading development projects is required. Spine or orthopedic experience is preferred. Work Authorization
US Work Authorization required Physical Demands
While performing the duties of this job, the employee is regularly required to stand, walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus Travel
Limited travel required; dependent on responsibilities and project load up to 15% of the time. Compensation
Pay range: $115,000 - $135,000 annual base salary. Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Please do not forward resumes to the TA/HR team or Spinal Elements employees. Spinal Elements is not responsible for any fees related to unsolicited resumes/applications.
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