Project Engineer
Carlsmed
Position Description
As Project Engineer, you will support the Product Development 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 collaborate with peripheral groups including Operations, Quality, Regulatory, and Markeing 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 or serve as a member of project teams involved in novel implant, instrument, and surgical planning solutions
- 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
- 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
- Assists Regulatory team by providing documentation and technical support for FDA submissions
- Provides engineering support to Manufacturing, Quality, Marketing, and Sales as necessary
- 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
Qualifications
- Education: Bachelor’s degree in Mechanical Engineering, Mechatronic Engineering, or Biomedical Engineering
- Experience: 4-6 years of industry experience with a minimum of 2 years in medical device product development
- Experience with spine or orthopedics highly desired
- Demonstrated ability to lead 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
- Strong ability to write technical and business reports and correspondence
- Strong 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 expected pay range is: $110K to $125K annually. Compensation may vary based on related skills, experience, and relevant key attributes.