Sr. Manufacturing Engineer
About The Position
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 As a Sr. Manufacturing Engineer, you will support the Advanced Manufacturing & Technology team’s goal of designing, validating, implementing and maintaining production processes for personalized aprevo® devices. You will be the owner of Additive Manufacturing process development and associated validations. You will have autonomy and be expected to identify solutions to problems on your own. In addition to developing and improving production processes, you will support the Surgical and Quality teams in the development of personalized devices. To be successful in this role, you must be a team-player, self-motivated, and invested in improving patient lives.
Requirements
- Technical Expertise in LPBF (Laser Powder Bed Fusion)
- Experience with nTop, Materialise and Python programming
- Experience with CAD software (Onshape, SolidWorks, Creo)
- Expertise in interpreting documents such as drawings, safety rules, company policy and industry regulations/standards
- Familiarity with sterilization and cleaning validation for medical devices
- 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 solutions
- Strong technical writing, and ability to translate requirements into clear concise documentation
- Proficiency with Microsoft Office with a strong ability to write business reports and correspondence
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science or equivalent
- 5-8 years of relevant engineering experience in a regulated environment required
- Strong understanding of ISO 13485 and FDA requirements for quality systems and medical devices
- Understanding of product design controls and risk management (ISO 14971)
- Experience scaling LPBF into serial production environment
Nice To Haves
- Experience with spine or orthopedics highly desired
Responsibilities
- Develop new/improve existing manufacturing processes for novel patient-specific products
- Transfer products and concepts from engineering to manufacturing to ensure seamless product scaling
- Conduct DFAM (Design for Additive Manufacturing) analysis for NPI (new product introduction) and modifications to existing products.
- Define best practices for build prep, support strategy, thermal management etc…
- Lead process efficiency initiatives, identify bottlenecks and implement improvements
- Own and drive pFMEA (Process Failure Modes and Effects Analysis)
- Author and approve validation documentation including IQ/OQ/PQ protocols, test methods, reports, sampling rationales, and traceability matrices
- Manage vendor relationships and work closely with vendors to aid in process/design transfer
- Support the Quality team in maintaining/developing Cleaning, Packaging and Sterilization processes
- Manage product/process changes through change control, assess impacts, and define revalidation requirements
- Define worst-case selection, acceptance criteria, sampling methods and testing coordination
- Provide support for investigations, nonconformances, and process troubleshooting (FMEA, NCRs, CAPAs)
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13584
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
