Associate Manager, Engineering

Position Description

As Associate Manager, Engineering, you will support the Product Development team’s goal of improving patient outcomes by developing new implants, instruments, and surgical planning systems. In addition to managing projects, you may manage a small team and help support other product development initiatives including product launches and process improvements. You will have autonomy and be expected to identify solutions to problems on your own. Lastly, you will support other cross-functional groups including the Operations, Regulatory, 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

• Directly responsible for the development of new product and or the enhancement of existing products


• Lead and/or support multiple projects simultaneously with the ability to prioritize and execute critical deliverables such as implant, instrument and surgical planning solutions


• May manage a small team of individuals with a focus on supporting their projects and their professional development


• Creates and supports the development of prototypes and processes using in-house or external resources


• Leverages CAD software 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


• Establishes protocols and documents technical assessments of mechanical design (eg FEA, tolerance analysis, testing, etc.)


• Provides support to current and future products manufactured in house or by outside vendors


• Supports cadaver labs during surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc


• Collaborates with Enabling Technologies and Case Planning teams to effectively define and execute project deliverables


• Collaborates with other cross-functional teams to assist with process improvement initiatives that enable Carlsmed to scale


• Assists Regulatory team by providing documentation and technical support for FDA submissions


• Provides engineering support to Manufacturing, Quality, Marketing, and Sales as necessary


• Reviews work for junior engineers and provides technical mentorship


• 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

• Education: Bachelor’s degree in Mechanical Engineering, Mechatronic Engineering, or Biomedical Engineering


• Experience: 6-10 years of industry experience with a minimum of 2 years in medical device product development


• Experience mentoring junior engineers and providing technical guidance and support


• Experience with spine or orthopedics highly desired


• Demonstrated success in leading product development from concept through product launch, including planning, organizing, and time management skills


• Experience in project management methods applied to the medical device industry (scope definition, work breakdown structure, timeline generation and resourcing, timeline execution and reporting)


• Solid understanding of traditional manufacturing methods for implants and instruments

Skills

• Excellent verbal and written communication; comfortable creating presentations and delivering them to senior management


• Strong ability to write technical and business reports and correspondence


• Exceptional mechanical design skills – able to generate high-quality concepts quickly


• Thorough and detail-oriented – able to execute complex technical work without errors or need for rework


• Willingness to wear multiple hats when needed to support Carlsmed’s mission


• Experience translating mechanical designs into manufacturable drawings/specifications and supporting designs throughout the design transfer process for successful product launches.


• Strong ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals

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.  Carlsmed  is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

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 & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The starting salary expected pay range is: $125,000 to $135,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.