Sr. Development Engineer

About Carlsmed

Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.

Position Description

The Senior Development Engineer designs and advances Carlsmed’s patient-specific implants, instruments, and surgical planning systems. This role owns new product development and continuous improvement initiatives, translating clinical and engineering requirements into manufacturable, regulatory-compliant designs. The Senior Development Engineer operates with technical autonomy and partners closely with Marketing, Quality, Regulatory, and Operations teams to ensure products are safe, effective, and scalable.

Responsibilities

• Support the development of new product designs and enhancements to existing platforms from concept through release


• Create and support prototypes and manufacturing processes using in-house and external development resources


• Design medical devices and instruments using CAD and rapid prototyping tools for traditional, novel, and additive manufacturing methods


• Produce engineering drawings, including dimensional and tolerance specifications


• Perform and document technical analyses (e.g.FEA, tolerance analysis, and benchtop verification testing)


• Create and maintain design control documentation in accordance with FDA and ISO 13485 requirements


• Support manufacturing of viable designs using in-house rapid prototyping equipment and external suppliers


• Collaborate with Marketing, Quality, Regulatory, and Operations to ensure designs meet regulatory, clinical, and production requirements


• Support cadaver labs and surgeon education activities, including setup, technical support, and procedural execution


• Deliver projects in accordance with approved timelines, quality standards, and regulatory requirements

Skills

• Ability to translate clinical and engineering requirements into functional mechanical designs


• Strong mechanical design, analysis, and documentation capability


• Proficiency in CAD development environments and mechanical testing methods


• Solid understanding of manufacturing processes and design-for-manufacturing principles


• Ability to interpret engineering drawings, technical specifications, and regulated documentation


• Strong written and verbal communication skills


• High level of technical ownership, accountability, and attention to detail

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Mechatronics, or a related field


• 2-4 years of mechanical engineering experience in a regulated medical device or similar environment


• Experience developing, implementing, and analyzing mechanical design solutions, including engineering calculations and test methods


• Experience with spine or orthopedic devices (Preferred)


• Experience in project management or supporting engineering projects (Preferred)

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

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. Compensation may vary based on related skills, experience, and relevant key attributes.