What are the responsibilities and job description for the Research Engineer (Biomechanical/Mechanical) position at Scismic?
Scismic is supporting the growth of an early stage biotechnology company backed by private and philanthropic foundation funding whose technology platform for DNA-based drug delivery is aimed at revolutionizing the development and accessibility of antibody and protein therapeutics for infectious diseases, blood disorders, and inflammatory and metabolic diseases.
Located in New York City, the company was founded on the principle that the remarkable medical benefits of antibody and protein therapeutics should be available to everyone.
The company is seeking a skilled and motivated Biomechanical/Mechanical Engineer to join their dynamic team. The successful candidate will play a crucial role in the design, development and optimization of electroporation devices and systems. This position requires a strong foundation in mechanical engineering principles and a passion for innovation in the biomedical field. The successful candidate must thrive in a highly dynamic, collaborative research environment and be committed to making significant contributions to the company's clinical and pre-clinical programs.
Key Responsibilities:
- Develop prototype electroporation devices which translate clinical needs into functional mechanical designs.
- Drive continuous improvement and innovation of the existing electroporation technology.
- Troubleshoot mechanical designs and manufacturing challenges.
- Conduct in silico simulations, as well as feasibility studies in animal models to evaluate design concepts and equipment performance.
- Perform testing and validation to ensure compliance with performance specifications and safety standards.
- Ensure compliance with risk management standards for medical devices.
- Lead collaborations with engineers, biomedical scientists, and CROs to integrate individual components into overall system designs.
- Analyze data, provide technical reports and documentation to support product development and participate in composing regulatory submissions.
- Participate in cross-functional team meetings and contribute to project planning and decision-making processes.
- Maintain meticulous documentation pertaining to DHF, DMR, QMS, and technical files.
Essential Qualifications:
- Master’s degree or PhD in Biomechanical/Mechanical Engineering or a related field.
- Proven experience in system design and development, preferably in the biomedical or medical device industry.
- Hands-on skills in prototyping (e.g., 3D printing, machining, soldering) and laboratory testing.
- Understanding of various MFG processes (e.g., P.I.M., sheet metal, machining, additive MFG).
- Experience with test fixture design and product validation testing.
- Proficiency in 3D CAD software (e.g., SolidWorks, AutoCAD, Creo, or Siemens NX).
- Knowledge of programming language for various software and hardware applications (e.g., Python, C, C , MatLab).
- Knowledge of regulatory standards and requirements for medical devices (e.g., ISO, standards, FDA regulations).
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills to work effectively in a team environment.
- Ability to manage multiple projects and prioritize tasks effectively.
Preferred Qualifications:
- Familiarity with embedded systems and firmware development.
- Understanding of human anatomy, physiology, and biomechanics.
- Knowledge of implantable devices, surgical instruments, and diagnostic tools.
- Animal handling, necropsy techniques, and tissue post-processing (histopathological experience is a plus).
- Experience conducting Failure Mode and Effects Analysis (FMEA).
- Knowledge of risk management standards for medical devices.
- Experience preparing Design History Files (DHF), Device Master Records (DMR) and Technical Files.
- Knowledge of verification and validation (V&V) processes.
- Experience with regulatory submissions.
- Knowledge of statistical software (e.g., Prism, Minitab).
- Proficiency in simulation software (e.g., ANSYS, COMSOL Multiphysics, or Abaqus).
- Knowledge of material selection, especially for biocompatible materials (e.g., titanium, stainless steel, polymers).
- Knowledge of sterilization techniques (e.g., autoclaving, gamma radiation, ethylene oxide).
- Tolerance stack-up analysis and GD&T (Geometric Dimensioning and Tolerancing).
- Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
- Understanding of mechanical testing methods (e.g., tensile, compression, fatigue).
Compensation and benefits:
- Attractive salary
- Performance bonus structure
- Equity
- 20 days paid vacation
- Medical, Dental, Vision, and Life Insurance
- 401(k) and other benefits
