Sr. Manufacturing Engineer
Carlsmed
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.
Key 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)
Skills
- 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
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13584
Qualifications
- Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science or equivalent
- Experience: 5-8 years of relevant engineering experience in a regulated environment required
- Experience with spine or orthopedics highly desired
- 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
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 accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation 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 and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $125,000 to $145,000. Compensation may vary based on related skills, experience, and relevant key attributes.