Managing Principal Engineer, Instruments and Accessories

General Description: 

The Managing Principal Mechanical Engineer will lead a small technical team developing complex medical disposables, including instruments and accessories used for robotic surgery. This individual will be the primary interface between various cross functional teams including Clinical, Marketing, Systems, Robotic Controls, Electrical Engineering, Software, Manufacturing and Operations. The ideal candidate will have past experience developing complex robotic medical devices alongside a diverse cross-functional team. We are looking for a self-motivated, proactive, well rounded individual willing to take ownership and operate with minimal supervision in a fast-paced startup environment. 

Responsibilities 

• Technical leadership for design & development of complex robotic medical devices, primarily including instruments and accessories.
• Lead a small (2-4 person) technical team focused on the same, providing guidance, mentorship and managerial support.
• This is a technical leadership role and the ideal candidate would maintain a level of individual contribution along with overall technical leadership.  
• Ability to create problem statements, concepts and have strong engineering expertise that guides our projects to a manufacturable, robust design for production.
• Develop and maintain detailed product development project plans with associated schedules and successfully execute against them.
• Interface between various cross-functional teams including Clinical, Marketing, Systems, Robotic Controls, Electrical Engineering, Software, Manufacturing and Operations to fully define product requirements and implement creative solutions in a fast-paced environment. 
• Lead the close collaboration with NPI and manufacturing team for seamless transfer of product to manufacturing.
• Lead the team in developing and documenting the finished product design documentation package including component and assembly drawings, product requirements, specifications, test methods, protocols and reports in support of V&V activities.
• Design and develop initial assembly processes including assembly/testing tools/fixtures to aid in assembly and conduct in process manufacturing quality assurance. 
• Participate and lead design reviews, dFMEA and other design de-risking & documentation activities. 
• Lead continuous improvement programs to improve the performance of the robotic instruments and accessories and/or reduce the cost and complexity of the same. 
• Manage and mentor less experienced engineers on the technical team and cross functionally to reach their full potential.

Requirements 

• 12 - 15 years of demonstrated success in design and development of complex medical devices, preferably experience with robotically controlled instruments and associated accessories. 
• Deep knowledge in medical device product development including single use disposables, robotic applications in medical space and/or endoluminal medical device development. 
• Experience with medical device sterilization processes, validations and packaging.
• Demonstrated ability to successfully design and develop complex mechanical products and manage, coach and develop a small team of engineers concurrently. 
• Ability to prioritize between critical project activities making appropriate trade-offs to successfully meet challenging project milestones. 
• Experience successfully commercially launching new products and smoothly transferring same to production while hitting COGS targets. 
• Hands on experience with risk analysis, risk mitigation and dFMEA. 
• Demonstrated success working with multi-disciplinary, cross functional teams. 
• Advanced SolidWorks user with experience using Solidworks CAD and Solidworks PDM tools. 
• Knowledge of regulatory standards such as IEC 60601-1 and FDA 510 (k) submission process 
• Familiarity with agile management tools such as Jira, Jama, Arena or similar. 
• Excellent communications skills and the ability to explain complex problems in plain language to cross functional teams. 
• Must have prior experience working in a fast-paced startup (or similar) environment. 
• B.S. degree in Mechanical, Bio-medical or related discipline. M.S degree or PhD preferred.

Workplace Type: Onsite

Benefits & Perks (For Full Time Employees):

• Competitive Salary
• Comprehensive health insurance including Medical, Dental and Vision HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental) and Disability insurance
• Mental health support through medical insurance programs
• Legal and Pet Insurance
• 12 paid holidays, 15-20 days of PTO use-what-you-need sick days
• Paid parental leave
• In-office snacks and beverages 
• In-office lunch stipend
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events

#LI-Onsite