HCLTech
Manufacturing Engineer Lead with medical device (El Paso)
HCLTech, El Paso, Texas, United States, 88568
HCLTech is looking for a highly talented and self- motivated Manufacturing Process Validation Lead to join it in advancing the technological world through innovation and creativity.
Job Title:
Manufacturing Process Validation Lead Job ID:
1605047BR Position Type:
Full-time with HCLTech Location:
Onsite, El Paso, Texas
Role/Responsibilities
Responsible for the Manufacturing Process Validation support activities toward attainment of departmental and plant goals. Primary focus is to play the Technical Leading role on Manufacturing process validation. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements. Ability to read, write and speak in English and Spanish.
Job Responsibilities: Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling Coordinates purchase and delivery of Equipment/Tooling Coordinates installation of Equipment/Tooling Develops and Executes IQ and OQ Protocols and Reports Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval of SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Develops Manufacturing Capacity Analysis Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops documentation/justification for assigned capital projects Complies with cGMPs, Quality Standards , and established policies and procedures Executes other duties assigned by his supervisor
Qualifications Knowledge and Skills: Bachelors degree in engineering Experience in the Medical Device Industries with experience in the Manufacturing Process Validation Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels. Qualification / Validation (IQ/OQ/PQ) Test Method Validation / Gage R&R Process Characterization / Design of Experiments (DOE) Manufacturing Line Design / Capacity Analysis Equipment / Tooling Design Equipment Installation / Preventive Maintenance Procedure Generation Root Cause Analysis / Investigation SOP / Manufacturing Procedures Generation & Change Control Product Financials & Supply Chain Structure Design OEE Integration, Vertical Start up and Zero-loss mindset Required Education and Experience: Requires a MS or bachelors degree in engineering or related field with 10+ years of experience in an engineering role
Pay and Benefits
Pay Range Minimum: $37.02 per hour Pay Range Maximum: $56.74 per hour
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to
secure@hcltech.com
for investigation.
Compensation and Benefits A candidates pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.
How Youll Grow
At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.
Job Title:
Manufacturing Process Validation Lead Job ID:
1605047BR Position Type:
Full-time with HCLTech Location:
Onsite, El Paso, Texas
Role/Responsibilities
Responsible for the Manufacturing Process Validation support activities toward attainment of departmental and plant goals. Primary focus is to play the Technical Leading role on Manufacturing process validation. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements. Ability to read, write and speak in English and Spanish.
Job Responsibilities: Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling Coordinates purchase and delivery of Equipment/Tooling Coordinates installation of Equipment/Tooling Develops and Executes IQ and OQ Protocols and Reports Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval of SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Develops Manufacturing Capacity Analysis Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops documentation/justification for assigned capital projects Complies with cGMPs, Quality Standards , and established policies and procedures Executes other duties assigned by his supervisor
Qualifications Knowledge and Skills: Bachelors degree in engineering Experience in the Medical Device Industries with experience in the Manufacturing Process Validation Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels. Qualification / Validation (IQ/OQ/PQ) Test Method Validation / Gage R&R Process Characterization / Design of Experiments (DOE) Manufacturing Line Design / Capacity Analysis Equipment / Tooling Design Equipment Installation / Preventive Maintenance Procedure Generation Root Cause Analysis / Investigation SOP / Manufacturing Procedures Generation & Change Control Product Financials & Supply Chain Structure Design OEE Integration, Vertical Start up and Zero-loss mindset Required Education and Experience: Requires a MS or bachelors degree in engineering or related field with 10+ years of experience in an engineering role
Pay and Benefits
Pay Range Minimum: $37.02 per hour Pay Range Maximum: $56.74 per hour
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to
secure@hcltech.com
for investigation.
Compensation and Benefits A candidates pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.
How Youll Grow
At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.