Embark on an enriching journey with PROCEPT BioRobotics, a company committed to revolutionizing treatment for benign prostatic hyperplasia through innovation in surgical robotics. As a Senior NPI Manufacturing Engineer, you will develop and transfer manufacturing processes for new product introductions, product changes, and enhancements, and be a key voice for manufacturing while interfacing with R&D.
Requirements
- Bachelor’s degree in engineering (Mechanical, Electrical, or related field) with 6+ years of experience, or Master’s degree in Engineering with 4+ years of experience in a regulated industry.
- Strong experience developing manufacturing processes, for Electromechanical assemblies.
- Background in medical device or capital equipment manufacturing within a regulated industry.
- Proven track record in NPI process development, DFx, and cross-functional project leadership
- Extensive experience with root cause analysis (RCA) and problem-solving for both technical and process issues.
- Experience with BOM creation, management, and change control.
- Preferred experience with Salesforce, QAD, or similar systems for BOM and change management.
- Familiarity with structured design processes (ISO 9000, FDA QSR) and regulatory approval requirements.
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485.
- Proficiency with CAD software (SolidWorks or similar).
- Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.
- Experience supporting capital equipment medical device manufacturing.
- Experience transferring highly technical projects to production in a cross functional environment.
- Proficiency in DFx principles: DFM, DFT, DFQ, DFR, DFC.
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Software/Firmware/Hardware experience – in large Electromechanical systems (Robotics systems a bonus)
- Six Sigma Black Belt certification & project executed with significant process improvement, cost saving or quality improvement.
- Familiar with DFM/DFX - Evaluation of part design, material selection, dimensional specifications. manufacturing methods and ease of assembly to reduce part count, improve efficiency and lower cost.
Benefits
- full medical coverage
- wellness programs
- on-site gym
- 401(k) plan with employer match
- short-term and long-term disability coverage
- basic life insurance
- wellbeing benefits
- flexible or paid time off
- paid parental leave
- paid holidays
