Sr. Development Engineer

Carlsmed • Carlsbad, CA

4d

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• Experience with spine or orthopedic devices (Preferred)
• Experience in project management or supporting engineering projects (Preferred)

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees