We are seeking a Project Engineer to join our growing Engineering team. This is an exciting opportunity to play a pivotal role in scaling the manufacturing of an innovative Class III medical device, driving process validation, continuous improvement, and the implementation of new processes from development through production.
Responsibilities
- Lead process improvement initiatives for the company's flagship product.
- Plan, execute, and document manufacturing process validation activities.
- Validate existing production processes to ensure compliance, consistency, and efficiency.
- Support the development, implementation, and transfer of new manufacturing processes into production.
- Collaborate closely with cross-functional teams, including R&D, Engineering, Quality, Production, and Operations.
- Identify opportunities to optimize processes to improve product quality, manufacturability, and operational efficiency.
- Ensure all process validation activities are performed in accordance with applicable quality and regulatory requirements.
Engineering Manager
RequirementsExperience
- A bachelor’s degree in mechanical or biomedical engineering, or a related field.
- 3–5 years of experience in product lifecycle development within the medical device industry.
- 1–3 years of hands-on experience with process validation activities, including technology transfer, IQ, DOE, OQ, and PQ.
- Experience with complex mechanical or materials-based manufacturing processes.
- Hands-on experience operating manufacturing equipment and production tools, with proven expertise in manufacturing process optimization.
- Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
- Familiarity with Process Validation Master Plans/Protocols (PVMP).
- Understanding of Test Method Validation processes.
Required Skills
- Proficiency in CAD software, particularly SolidWorks.
- Experience with data analysis and statistical software, such as JMP and/or Minitab.
- Strong problem-solving, analytical, and troubleshooting capabilities.
- Proven ability to work effectively within cross-functional teams.
- Strong written communication skills in English.
- Excellent interpersonal and relationship-building skills.
Skills Required
- Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field
- 3–5 years of product lifecycle development experience in the medical device industry
- 1–3 years of hands-on process validation experience, including technology transfer, IQ, DOE, OQ, and PQ
- Experience with complex mechanical or materials-based manufacturing processes
- Hands-on experience operating manufacturing equipment and production tools
- Expertise in manufacturing process optimization
- Knowledge of DFMEA and PFMEA risk assessment methodologies
- Familiarity with Process Validation Master Plans and Protocols
- Understanding of Test Method Validation processes
- Proficiency in CAD software, particularly SolidWorks
- Experience with statistical and data analysis software such as JMP or Minitab
- Strong problem-solving, analytical, and troubleshooting skills
- Ability to work effectively with cross-functional teams
- Strong written communication skills in English
- Excellent interpersonal and relationship-building skills
What We Do
Magenta Medical is a Class III medical-device company developing the Elevate™ System, described as the world’s smallest and most powerful heart pump. The system is intended to provide minimally invasive support during acute episodes of heart dysfunction. Its multidisciplinary work spans mechanical and electrical engineering, materials science, software, algorithms, and advanced catheter fabrication, as the company moves toward commercial manufacturing and market introduction.
