The Senior Engineer, Product Development is a professional that applies knowledge of engineering to lead and technically support the development of medical devices. They utilize knowledge and expertise to resolve critical issues and successfully commercialize products. Employees in this role have had success as technical members of cross functional project teams and have the skills necessary to lead projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
- Manage all phases of Product Development, including conception, design, specifications, prototyping, verification, validation, risk management, project management, process development, management updates and design transfer.
- Lead cross functional teams.
- Apply engineering knowledge and expertise to resolve crucial issues and/or unique conditions.
- Develop next generation neurological medical devices.
What are we looking for?
QualificationsDESIRED MINIMUM QUALIFICATIONS
- B.S., M.S., PhD degree in an engineering discipline with 5 or more years of applied experience.
- Experience developing medical devices from concept through commercial release.
- Demonstrates mechanical skills.
- Demonstrates organizational and project management skills.
- Proficiency in data analysis and data analysis software (Minitab, Excel).
- Strong understanding of FDA QSR and ISO 13485 medical device regulations.
- Proficiency in Computer Aided Design software, such as Solidworks or Onshape.
- Proficiency in Risk Management (UFMEA, DFMEA, PFMEA)
- Professional communication skills, verbal and written.
- Advanced troubleshooting / problem solving skills.
- Experience working with operations to ensure smooth product transitions from design to manufacturing.
- Experience utilizing a wide range of fabrication techniques.
- Proficiency applying ASME Y14.5 drafting standards.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required.
- Computer aided design software (Onshape, Solidworks)
- Project management software (Microsoft Project)
- Basic shop tools (Drill press, 3D printer, lathe, mill etc.)
- Basic electronic tools (multimeter, solder, wire cutters)