Sr. Manufacturing Mechanical Engineer - Fortive Corporation
Irvine, CA
About the Job
The Sr. Manufacturing Mechanical Engineer will identify and ensure validation of opportunities to optimize/improve
manufacturing processes of medical device consumables. Apply processes including using engineering
methodologies (e.g. Six Sigma and LEAN) employing technical design skills, including SolidWorks, to re-design/design of semi-automated/fully automated equipment, tools, fixtures meet standards. Hands-on
experience with equipment operations and repair is a plus to drive DFX (design for reliability, design for
manufacturability, design for maintainability). The individual will develop and ensure that manufacturing
processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and
compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six
Sigma, Design for Manufacturing and Design for Cost Methodologies. The Manufacturing Mechanical Engineer
will act as a liaison between Manufacturing, R&D, Supplier Quality, Procurement, Quality, and team members
assigned to the project.
Responsibilities to include support for all manufacturing processes including welding, and/or packaging,
modifications and upgrades to existing equipment, design and selection of component modifications, preparation
of estimates, submission for capital funding, timely execution of installations, equipment commissioning and
validation, development and periodic review of standard operating procedures and specifications, testing
procedures and specifications, documentation revisions, non-conformance reports, failure investigations, change
orders, corrective action/preventive action documentation, and manufacturing project scheduling and
coordination.
Will also be responsible for introducing new manufacturing technologies to support existing manufacturing
processes and equipment; addresses daily technical issues and challenges in manufacturing and operations.
May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous
improvement opportunities utilizing methodologies, such as Lean/Six Sigma, DFM, DFX, SPC, etc. Follows
domestic and international regulatory standards (e.g., GMP and ISO 13485).
Duties and Responsibilities
• Under limited supervision and in accordance with all applicable government laws, regulations
and ASP policies, procedures and guidelines, this position:
• Apply broad engineering and scientific and Fortive Business Systems knowledge to the development and
improvement of existing products, associated processes, and semi-automated/fully automated
manufacturing processes for manufacturing equipment.
• Evaluate manufacturing processes / products and collaborates with Software Quality Engineering, R&D,
IT, Quality, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity
and reduce costs.
• Perform and execute process validations as required, IQ/OQ/PQ, SDLC; generate protocols and test
reports.
• Develop complex experiments and tests (including writing and executing protocols) to validate
manufacturing processes; analyze results, make recommendations, and develop reports.
• Troubleshoot production line issues related to yield, quality, and throughput. Ability to determine root
cause by using methodologies as but not limited to 8D’s, DMAIC, RCCM, Fishbone, 5 Why’s for failure
investigations and implement solutions using risk-based decision making.
• Design, develop, implement, and improve manufacturing processes and equipment.
• Design and develop troubleshooting guides and decision-making matrices to ensure the standard
application of methods in the resolution of process/ manufacturing technical issues.
• Create user-friendly, pictorial based manufacturing procedures for users and Manufacturing Technicians.
• Provide technical training and guidance to Manufacturing Technicians and Manufacturing Engineering
personnel.
• Work independently and in cross-functional teams (both internal and external) to disposition non-conforming materials, determine root cause, lead / implement robust counter measures and appropriate
corrective actions, preventive actions for processes and manufacturing related issues. Exercise
judgment within generally defined practices and policies in selecting methods and techniques for
obtaining solutions.
• Lead/support continuous improvement projects and initiatives using Fortive Business Systems, Lean and
Six Sigma methodologies.
• Support and provide input to Process Failure Mode and Effects Analyses of equipment.
• Support supplier qualifications and assist in new supplier selection process.
• Continuously research, learn, and recommend best practices for world-class semi-automated/fully
automated manufacturing processes.
• Analyze proposals and cost estimates of equipment supplier related costs or cost improvements with
Contracts team and cross-functional team.
• Provide guidance to lower-level engineers and related project team members.
• Provide technical support for external suppliers and external operating companies.
• Maintain training records and always follow manufacturing and safety procedures.
• Act as technical liaison between R&D Engineering, Quality Engineering and Manufacturing.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed
Qualifications:
B.S. in Mechanical Engineering discipline, with a minimum of 4 years of experience in plant manufacturing,
machine design, repair, reliability and maintainability (DFX).
Years of Related Experience:
▪ A minimum of 4 years of Previous experience in mechanical engineering, manufacturing or related
background is required.
▪ Worked a minimum of 4 years in a medical/pharmaceutical manufacturing environment.
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
▪ Ability to use and apply standard principles, theories, and concepts in Engineering.
▪ Proficiency with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports.
▪ Experience and ability to troubleshoot simple to complex manufacturing process issues.
▪ Proficiency in SolidWorks and CAD design.
▪ Proven expertise in use of MS Office Suite including MS Project.
Ability to review engineering product specifications, CAD data/GD&T, drawing, as part of design review
process to ensure they meet industry and manufacturing standards and practices.
▪ Excellent conceptual, analytical, and problem-solving ability.
▪ Experience with processing, dispensing, and packaging of biochemical products.
▪ Experienced and skilled with data analysis including the use of statistical tools such as Minitab.
▪ Excellent communication skills, both verbal and written, and the ability to effectively interface within a
cross-functional team environment including consultative and relationship management skills.
▪ Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Preferred Certifications, licenses, and affiliations:
▪ Experience working in an ISO 13485, GMP, or FDA regulated environment is desirable.
▪ Experience with continuous improvement methodologies (i.e., Lean, Six Sigma).
▪ Preferred experience in the following: MS Project, demonstrated skills in developing, writing, and
executing cGMP-based process and semi/fully automated equipment validations and robotics.
▪ Lean Six Sigma Black Belt Certification
Responsibility for Others and Internal Interactions
▪ Indirectly manage support for validations from Manufacturing Engineering, Sr. Technician Specialist.
▪ Potential internal interface activities include collaboration with cross-functional team (e.g. Quality
Engineering, Software Quality Engineering, Quality Inspection, Procurement, Microbiology and Chemistry
laboratories, Facilities, Regulatory and Warehouse).
External Interactions
• Interaction with equipment suppliers, external manufacturers, engineers, and project managers for qualifications
and equipment design.
• Potential annual interactions with government agencies, Competent Authorities audits.
Physical & Work Environment Requirements
Physical Requirements:
The physical demands identified are representative of the physical requirements necessary for an employee to
successfully perform the essential functions of this job. Reasonable accommodation can be made to enable
people with disabilities to perform the described essential functions of this job. While performing the
responsibilities of this job, the employee may be required to talk and hear.
Work Environment
-Scheduled Work Hours
-Shift Work
-On Call (Call in for Work)
Approximate Position Requirements
Standing: Up to 30%
Kneeling: 0-10%
Sitting: Up to 90%
Walking: Up to 30%
Controlled environment room gowning
This position primarily involves day shift work. However, candidates should be prepared for occasional
after-hours, weekend, and shift work as needed
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
The salary range for this position (in local currency) is 79,700.00 - 147,900.00
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
manufacturing processes of medical device consumables. Apply processes including using engineering
methodologies (e.g. Six Sigma and LEAN) employing technical design skills, including SolidWorks, to re-design/design of semi-automated/fully automated equipment, tools, fixtures meet standards. Hands-on
experience with equipment operations and repair is a plus to drive DFX (design for reliability, design for
manufacturability, design for maintainability). The individual will develop and ensure that manufacturing
processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and
compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six
Sigma, Design for Manufacturing and Design for Cost Methodologies. The Manufacturing Mechanical Engineer
will act as a liaison between Manufacturing, R&D, Supplier Quality, Procurement, Quality, and team members
assigned to the project.
Responsibilities to include support for all manufacturing processes including welding, and/or packaging,
modifications and upgrades to existing equipment, design and selection of component modifications, preparation
of estimates, submission for capital funding, timely execution of installations, equipment commissioning and
validation, development and periodic review of standard operating procedures and specifications, testing
procedures and specifications, documentation revisions, non-conformance reports, failure investigations, change
orders, corrective action/preventive action documentation, and manufacturing project scheduling and
coordination.
Will also be responsible for introducing new manufacturing technologies to support existing manufacturing
processes and equipment; addresses daily technical issues and challenges in manufacturing and operations.
May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous
improvement opportunities utilizing methodologies, such as Lean/Six Sigma, DFM, DFX, SPC, etc. Follows
domestic and international regulatory standards (e.g., GMP and ISO 13485).
Duties and Responsibilities
• Under limited supervision and in accordance with all applicable government laws, regulations
and ASP policies, procedures and guidelines, this position:
• Apply broad engineering and scientific and Fortive Business Systems knowledge to the development and
improvement of existing products, associated processes, and semi-automated/fully automated
manufacturing processes for manufacturing equipment.
• Evaluate manufacturing processes / products and collaborates with Software Quality Engineering, R&D,
IT, Quality, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity
and reduce costs.
• Perform and execute process validations as required, IQ/OQ/PQ, SDLC; generate protocols and test
reports.
• Develop complex experiments and tests (including writing and executing protocols) to validate
manufacturing processes; analyze results, make recommendations, and develop reports.
• Troubleshoot production line issues related to yield, quality, and throughput. Ability to determine root
cause by using methodologies as but not limited to 8D’s, DMAIC, RCCM, Fishbone, 5 Why’s for failure
investigations and implement solutions using risk-based decision making.
• Design, develop, implement, and improve manufacturing processes and equipment.
• Design and develop troubleshooting guides and decision-making matrices to ensure the standard
application of methods in the resolution of process/ manufacturing technical issues.
• Create user-friendly, pictorial based manufacturing procedures for users and Manufacturing Technicians.
• Provide technical training and guidance to Manufacturing Technicians and Manufacturing Engineering
personnel.
• Work independently and in cross-functional teams (both internal and external) to disposition non-conforming materials, determine root cause, lead / implement robust counter measures and appropriate
corrective actions, preventive actions for processes and manufacturing related issues. Exercise
judgment within generally defined practices and policies in selecting methods and techniques for
obtaining solutions.
• Lead/support continuous improvement projects and initiatives using Fortive Business Systems, Lean and
Six Sigma methodologies.
• Support and provide input to Process Failure Mode and Effects Analyses of equipment.
• Support supplier qualifications and assist in new supplier selection process.
• Continuously research, learn, and recommend best practices for world-class semi-automated/fully
automated manufacturing processes.
• Analyze proposals and cost estimates of equipment supplier related costs or cost improvements with
Contracts team and cross-functional team.
• Provide guidance to lower-level engineers and related project team members.
• Provide technical support for external suppliers and external operating companies.
• Maintain training records and always follow manufacturing and safety procedures.
• Act as technical liaison between R&D Engineering, Quality Engineering and Manufacturing.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed
Qualifications:
B.S. in Mechanical Engineering discipline, with a minimum of 4 years of experience in plant manufacturing,
machine design, repair, reliability and maintainability (DFX).
Years of Related Experience:
▪ A minimum of 4 years of Previous experience in mechanical engineering, manufacturing or related
background is required.
▪ Worked a minimum of 4 years in a medical/pharmaceutical manufacturing environment.
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
▪ Ability to use and apply standard principles, theories, and concepts in Engineering.
▪ Proficiency with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports.
▪ Experience and ability to troubleshoot simple to complex manufacturing process issues.
▪ Proficiency in SolidWorks and CAD design.
▪ Proven expertise in use of MS Office Suite including MS Project.
Ability to review engineering product specifications, CAD data/GD&T, drawing, as part of design review
process to ensure they meet industry and manufacturing standards and practices.
▪ Excellent conceptual, analytical, and problem-solving ability.
▪ Experience with processing, dispensing, and packaging of biochemical products.
▪ Experienced and skilled with data analysis including the use of statistical tools such as Minitab.
▪ Excellent communication skills, both verbal and written, and the ability to effectively interface within a
cross-functional team environment including consultative and relationship management skills.
▪ Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Preferred Certifications, licenses, and affiliations:
▪ Experience working in an ISO 13485, GMP, or FDA regulated environment is desirable.
▪ Experience with continuous improvement methodologies (i.e., Lean, Six Sigma).
▪ Preferred experience in the following: MS Project, demonstrated skills in developing, writing, and
executing cGMP-based process and semi/fully automated equipment validations and robotics.
▪ Lean Six Sigma Black Belt Certification
Responsibility for Others and Internal Interactions
▪ Indirectly manage support for validations from Manufacturing Engineering, Sr. Technician Specialist.
▪ Potential internal interface activities include collaboration with cross-functional team (e.g. Quality
Engineering, Software Quality Engineering, Quality Inspection, Procurement, Microbiology and Chemistry
laboratories, Facilities, Regulatory and Warehouse).
External Interactions
• Interaction with equipment suppliers, external manufacturers, engineers, and project managers for qualifications
and equipment design.
• Potential annual interactions with government agencies, Competent Authorities audits.
Physical & Work Environment Requirements
Physical Requirements:
The physical demands identified are representative of the physical requirements necessary for an employee to
successfully perform the essential functions of this job. Reasonable accommodation can be made to enable
people with disabilities to perform the described essential functions of this job. While performing the
responsibilities of this job, the employee may be required to talk and hear.
Work Environment
-Scheduled Work Hours
-Shift Work
-On Call (Call in for Work)
Approximate Position Requirements
Standing: Up to 30%
Kneeling: 0-10%
Sitting: Up to 90%
Walking: Up to 30%
Controlled environment room gowning
This position primarily involves day shift work. However, candidates should be prepared for occasional
after-hours, weekend, and shift work as needed
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
The salary range for this position (in local currency) is 79,700.00 - 147,900.00
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Source : Fortive Corporation