Sr. Development Engineer

*About Carlsmed®* Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The company’s aprevo® devices are personalized to improve the standard of care for the surgical treatment of adults with spinal malalignment. Carlsmed uses patient data and proprietary digital technologies to create optimal surgical plans and personalized aprevo® spine fusion devices to align with the surgeon’s goals for each patient. Carlsmed has an exciting opportunity for a Supply Chain Specialist. *Position Description* As *Sr. Development Engineer*, you will support Surgical team’s goal of improving patient outcomes by developing new implants, instruments, and surgical planning systems. You will be the *owner of new product development and existing product improvement projects*. You will have autonomy and be expected to identify solutions to problems on your own. In addition to developing and improving products, you will support the Operations and Quality teams as we build the first-in-industry, scalable patient-specific process. To be successful in this role, you must be a team-player, *self-motivated*, and *invested in improving patient lives.* *Responsibilities* * Creates and supports the development of prototypes and processes using in-house or external resources * Leverages CAD software or in-house rapid prototyping equipment to design medical devices and instruments suitable for a traditional, novel, and additive manufacturing methods * Specifies engineering drawings, including assignment of dimensions and tolerances to designs * Creates and maintains documentation relevant to design control and other applicable regulatory requirements * Documents technical assessments of mechanical design (eg FEA, tolerance analysis, testing, etc.) * Supports manufacturing of viable designs using in-house rapid prototyping equipment or by outsourcing to external suppliers * Supports cadaver labs during surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc * Adheres to project delivery schedules and performs duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485 * Performs other duties as assigned *Qualifications* * Bachelor’s degree in *Mechanical Engineering, Mechatronic Engineering, or Biomedical Engineering* * *2-5* years of *Mechanical Engineering *experience in a regulated environment required * Experience with spine or orthopedics_ *highly desired*_ * Project management experience highly desired * Experience in implementing and analyzing mechanical design solutions, including the ability to perform mechanical design calculations *Skills* * Excellent verbal and written communication * Ability to perform high quality work with speed * Willingness to wear multiple hats when needed to enable excellent patient outcomes * Ability to translate requirements into functional mechanical solutions * Experience with the CAD development environment, component data sheets, and mechanical test methods and equipment * Strong ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals * Understanding of manufacturing processes and design for manufacturing * Proficiency with Microsoft Office with a strong ability to write business reports and correspondence * Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13584 *Equal Opportunity Employer* Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. *Compensation* At Carlsmed, our employees are our most valued asset. Our benefits reflect our investment in the overall health and well-being of our employees and their families. We pleased to provide a competitive salary and benefits, including paying 100% of monthly healthcare and dental insurance premiums and a 401(k) plan with employer matching. Job Type: Full-time Pay: $100,000.00 - $130,000.00 per year Benefits: * 401(k) * Dental insurance * Health insurance * Tuition reimbursement * Vision insurance Work Location: In person