Primary Function of Position
At Intuitive, we believe that minimally invasive care is life-enhancing care. We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients. We use creative techniques to solve hard problems in order to achieve optimal clinical performance, manufacturabilty and reliability.
Within Intuitive, the Single Port robotic platform offers surgeons the ability to perform surgeries through a single incision with boundless possibilities. The Sr. Manufacturing Engineering Manager is responsible for leading and directly contributing to the development of manufacturing processes. This position requires a ‘player / coach’, capable of both strategic technical contributions as well as leadership of a team of multidisciplinary engineers, technicians, and team support members. The role is responsible for a team collaborating with cross functional teams to discover, define, design, develop, and validate new assembly and test processes as well as sustaining and improving them in the achievement of quality, capacity, and cost goals for ISI’s manufacturing operations. The ideal candidate will have experience achieving results working with a team to optimize their potential in being successful.
Essential Job Duties
- Lead a team of manufacturing engineers supporting the process development and commercialization of robotic surgical instruments and accessories products. This includes the full evolution to launch new products and sustain their continued delivery with optimization. Individual contribution working closely with the team will often be required to meet the team deliverables.
- Establish group & objectives, priorities, and metrics.
- Ensure the professional development of team members is planned and completed. Plan, budget and staff projects, tracking performance throughout.
- Interface and effectively participate in the design process with DFA, DFX and general manufacturing requirements. Develop strategic manufacturing & capacity plans for new product introduction. Responsible for the design transfer process ensuring expected quality and manufacturing priorities are met. Evaluate and challenge designs for technical merit, working with the supply engineering and design teams to realize optimal outcomes.
- Recognize and attract top talent and invest in mentorship and training to retain and support the career development of team members
- Foster an environment that encourages creativity, risk taking, inclusive collaboration, and timely execution
- Navigate complex technical and programmatic situations driving timely decision making, providing detailed planning and setting appropriate team priorities to achieve success
- Establish group targets and personal work goals consistent with overall equipment development and business unit operational goals
- Manage team generation of formal process development and documentation that facilitates a high quality standard for scalability, and continuous improvement, reviewed cross-functionally, and controlled through product level management release.
- Review, examine & manage process risk in the manufacturing environment (PFMEA), associated mitigations, critical to quality inputs and controls. Oversee the validation and qualification of manufacturing equipment and processes qualification (IQ/OQ/DQ/PQ/PPQ)
- Support duplication and line transfers
- Supports technical investigation and resolution for failure analysis of discrepant components discovered during assembly, assemblies and field returns.
- Drives continuous improvement initiatives focused on optimum processes, and operational manufacturing line activities (e.g. improvements to process quality, efficiency, performance consistency, capacity, and cost).
Required Skills and Experience
- Proven capability to manage diverse teams developing processes with manufacturing and test equipment to optimize performance with mechanical, software, algorithms, human interface and electronics aspects.
- In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
- Excellent engineering skills with proficiency in assembly equipment design is required. Must have proven ability in assembly and test process development and integration of equipment to meet process priorities.
- Excellent mechanical design and analysis skills. Broad knowledge of “First Principles” engineering fundamentals. Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solving
- Proficient in SolidWorks or equivalent CAD software
- Extensive process and fixture design experience, including thorough documentation, reliability, serviceability, and equipment qualification
- Fundamental understanding of lean six sigma and design for assembly, manufacturing, and automation principles (DfX)
- Familiarity with medical device reprocessing and sterilization and design of single use products and processes
- Familiarity with small part assembly and manufacture
- A passion for creating high quality robust and reliable products
- Personally motivated to fundamentally understand challenging technical problems and drive implementation of efficient and high quality solutions
- Demonstrated knowledge of component manufacturing processes (including injection molding, machining, MIM, advanced 3D printing, heat treatment, and other post-processes)
- Proven ownership of technical problem solving with ability to identify root cause and drive corrective actions
- Effective communication skills (verbal, written, and presentation)
- Proven people leadership skills – ability to energize and empower a team and unite them in a common goal
- Demonstrated project leadership and exceptional communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation followed by continuous improvement.
Required Education and Training
- Minimum Bachelors degree in Mechanical Engineering or Equivalent
- Minimum of 2 years management experience
Preferred Skills and Experience
- Master’s degree or higher preferred in Mechanical Engineering
- Minimum 10 years experience with process development.
- Experience taking commercial products through entire design, development, and implementation launch cycle.
- Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a plus
- Experience in manufacturing and assembly automation highly desired.
- Medical device experience preferred.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
