Company Description

Job Description

Primary Function of Position
Be responsible for overseeing and managing aspects of the manufacturing engineering department.  The person in this position will be a technical leader that is expected to manage, lead and 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.  This position requires a strong background in engineering, manufacturing processes and project management.

Essential Job Duties

• Develop and implement manufacturing strategies and processes to improve productivity and enhance product quality.
• Lead and manage a team 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.
• Develop and maintain manufacturing engineering standards, procedures and best practices.
• Oversee the design, development, and implementation of new manufacturing processes and technologies.
• Monitor and analyze key performance indicators (KPIs) to identify areas for improvement and implement corrective actions.
• Lead the identification and implementation of process improvements, including lean manufacturing techniques, to optimize production efficiency and reduce scrap.
• Work closely with team to inform the automation and equipment team requirements needed for future manufacturing line designs.
• Manage the maintenance of manufacturing documentation, including work instructions, standard operating procedures, and quality control plans.
• 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 team 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)
• Collaborate with vendors and suppliers to evaluate and select equipment, tools, and materials for manufacturing processes.
• Focus on continuous improvement efforts; able to evaluate, prioritize and drive implementation of those efforts

Qualifications

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.
• Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously.
• Continuous learning mindset and willingness to stay updated with industry advancements.

Required Education and Training

• Minimum Bachelor's degree in Engineering or a related field.
• Proven experience in manufacturing engineering, with at least 8 years in a leadership role.
• 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

Additional Information

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.

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