Primary Function of Position
Be responsible for overseeing and optimizing our manufacturing processes to ensure efficiency, quality, and cost-effectiveness. The person in this position will be a technical leader that is expected to mentor other manufacturing engineers within the larger team as well as train others in cross-functional teams to ensure seamless transition of new products to manufacturing.
Essential Job Duties
- Develop and implement manufacturing strategies and processes to improve productivity and enhance product quality.
- Mentor teams of manufacturing engineers, providing guidance and support to ensure successful execution of projects.
- Collaborate with cross-functional teams, including design, production, and quality assurance, to ensure seamless integration of manufacturing processes.
- Conduct feasibility studies and cost analysis to determine the most efficient manufacturing methods and equipment.
- Identify and implement process improvements, including lean manufacturing techniques, to optimize production efficiency and reduce scrap.
- Work closely with and inform the automation and equipment team requirements needed for future manufacturing line designs.
- Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, and quality control plans.
- Monitor and analyze production data to identify trends, troubleshoot issues, and implement corrective actions.
- Stay updated with industry trends and advancements in manufacturing technology, and recommend innovative solutions to enhance our manufacturing capabilities.
- Ensure compliance with regulatory requirements and industry standards, such as ISO and FDA regulations.
- Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
- Lead effort in development and optimization of process validations (IQ/OQ/PQ)
- Focus on continuous improvement efforts; able to evaluate, prioritize and drive implementation of those efforts
Required Skills and Experience
- Technical expertise in Design Controls, process validations, Gage R&R and requirements traceability
- Technical expertise in the development of proper process FMEAs
- Technical expertise and support to resolve complex manufacturing issues
- Strong knowledge of FDA/ISO regulatory requirements and quality management systems.
- Excellent leadership and team management skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work collaboratively in a fast-paced, high-pressure and cross-functional team environment.
- Ability to demonstrate oneself to senior management as an expert who will influence changes, implementation strategies, etc.
- Ability to evaluate and develop new technology, tools and processes that improve the overall business
Required Education and Training
- Bachelor's degree in Engineering or a related field.
- Minimum of ten (10) years of experience in medical device manufacturing with BS or, six (6) years of experience with MS or PhD degree.
- Proven experience as a Manufacturing Engineer and leader, with a focus on process optimization and improvement.
Preferred Skills and Experience
- Knowledge of lean manufacturing principles and Six Sigma methodologies.
- Tooling and Equipment design
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 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.
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.
