Principal Engineer , R&D
Domain
Tech Stack
Must-Have Requirements
- ✓BSME degree
- ✓Minimum 12 years working experience with medical devices, robotic surgery systems, and/or medical implants
- ✓Strong leadership skills
- ✓Proficiency with SolidWorks CAD
- ✓Experience with all phases of product development lifecycle
- ✓Experience designing surgical products in FDA or other regulated industry
- ✓Strong mechanical design and analysis skills
- ✓Ability to communicate effectively across all levels
Nice to Have
- -MSME degree
- -Product-minded mindset
- -Experience with outside consultants collaboration
- -Clinical device field support experience
Description
Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
What Your Day-To-Day Will Involve
Lead design teams, provide technical leadership, and facilitate the successful execution of the Design Control and Quality Engineering Processes.
Oversee product development activities from concept to regulatory approval.
Collaborate with other engineering disciplines (software, electrical, systems, manufacturing) on the design and development of consumables and accessories.
Provide design, integration and test solutions in a fast-paced environment with a quick development cycle.
Identify and resolve technical issues to ensure feasibility and sustainability of products. Perform technical design reviews to solicit feedback on design progress Work closely with cross-functional departments to develop robust, scalable assembly processes that are cost-efficient and ready for high volume production.
Support prototype clinical devices in the field.
Make decisions based on risk assessment, industry standards, and regulatory framework.
Assist in the development of manufacturing fixtures and instrumentation.
Collaborate and lead design initiatives with outside consultants.
Interface with vendors in a lead role, for component sourcing and fabrication.
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. Understand and adhere to the PROCEPT BioRobotics Quality Policy & EHS Policies
The Qualifications We Need You to Possess BSME required, MSME preferred. Minimum of 12 years of working experience with medical devices, robotic surgery systems, and/or medical implants.
Strong leadership skills with a proven ability to manage multiple technical projects effectively.
Highly desirable for a product minded individual, with the ability to combine complex mechanical systems into a product that meets or exceeds patient and physician needs.
Extensive experience with all phases of the product development lifecycle including design, implementation, verification, qualification, and transfer to manufacturing.
Proficiency using CAD to design and document mechanisms: SolidWorks (required).
Strong understanding of component selection criteria, and design for reliability and manufacturability.
Demonstrated ability to design for manufacturing and assembly (DFx).
Proven experience with developing criteria for outsourced products and the subsequent managing of those programs.
Experience with designing surgical products in an FDA or other regulated industry; strong experience with concepts of design input, design output, traceability, and risk analysis.
Ability to communicate effectively (written, oral) across all levels and organizations.
Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis. Top of Form