SEDAA
Senior Medical Device Manufacturing Engineer
SEDAA, Pleasanton, California, United States, 94566
Local candidates to US only – no C2C
Job title – Production Engineer/ Specialist Location – Pleasanton, CA (fully onsite)
This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Main Responsibilities
Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Evaluation of production equipment.
Production support and process validation.
Interface with vendors for incoming components.
Troubleshoot manufacturing process and equipment.
Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes.
Apply manufacturing concepts such as Value Stream Mapping, 5S, and Visual Workplace to improve quality, labor efficiency, and throughput.
Protocol and report writing.
Generate and modify manufacturing process documentation.
Work with cross‑functional teams as required.
Develop and implement process improvements.
Support all Company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments while maintaining positive communication and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities on occasion, as assigned.
Education Requirement Bachelor’s Degree (± 16 years) in Mechanical, Industrial, Chemical, Biomedical or related Engineering area, or an equivalent combination of education and work experience.
Experience/Background
Minimum of 3 years Manufacturing engineering experience required. Previous medical device experience preferred.
Experience working in a broader enterprise/cross‑division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner.
Strong organizational and follow‑up skills, as well as attention to detail.
Ability to travel approximately 25%, including internationally.
Local candidates to US only – no C2C
Job title – Senior Manufacturing & Production Engineer Location – Pleasanton, CA (fully onsite)
This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Main Responsibilities
Manage projects including new production equipment, process improvements, and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians.
Provide technical mentorship to engineers and technicians.
Conduct Process FMEAs and Process Validations.
Improve product quality, labor efficiency, and throughput through Lean manufacturing concepts.
Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment.
Work with Product Development to ensure Design for Manufacturability.
Individual should be innovative, resourceful, and work with minimal direction; possess excellent organization, problem‑solving, communication, and team leadership skills and work effectively with cross‑functional teams.
Support all Company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
Comply with U.S. FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments while maintaining positive communication and collaboration with all levels of employees, customers, contractors, and vendors.
Education Requirements Bachelor’s Degree (± 16 years) in Mechanical, Chemical, or any engineering or technical degree, or an equivalent combination of education and work experience.
Experience Details
Minimum 5 years Manufacturing engineering experience, with medical device experience required; international manufacturing experience preferred.
Strong analytical, problem‑solving, and project management skills. Six Sigma certification preferred.
Demonstrated leadership capability in team settings. Experience working in a broader enterprise/cross‑division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment, and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow‑up skills, and attention to detail.
Ability to travel approximately 25%, including internationally.
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Job title – Production Engineer/ Specialist Location – Pleasanton, CA (fully onsite)
This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Main Responsibilities
Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Evaluation of production equipment.
Production support and process validation.
Interface with vendors for incoming components.
Troubleshoot manufacturing process and equipment.
Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes.
Apply manufacturing concepts such as Value Stream Mapping, 5S, and Visual Workplace to improve quality, labor efficiency, and throughput.
Protocol and report writing.
Generate and modify manufacturing process documentation.
Work with cross‑functional teams as required.
Develop and implement process improvements.
Support all Company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments while maintaining positive communication and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities on occasion, as assigned.
Education Requirement Bachelor’s Degree (± 16 years) in Mechanical, Industrial, Chemical, Biomedical or related Engineering area, or an equivalent combination of education and work experience.
Experience/Background
Minimum of 3 years Manufacturing engineering experience required. Previous medical device experience preferred.
Experience working in a broader enterprise/cross‑division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner.
Strong organizational and follow‑up skills, as well as attention to detail.
Ability to travel approximately 25%, including internationally.
Local candidates to US only – no C2C
Job title – Senior Manufacturing & Production Engineer Location – Pleasanton, CA (fully onsite)
This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
Main Responsibilities
Manage projects including new production equipment, process improvements, and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians.
Provide technical mentorship to engineers and technicians.
Conduct Process FMEAs and Process Validations.
Improve product quality, labor efficiency, and throughput through Lean manufacturing concepts.
Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment.
Work with Product Development to ensure Design for Manufacturability.
Individual should be innovative, resourceful, and work with minimal direction; possess excellent organization, problem‑solving, communication, and team leadership skills and work effectively with cross‑functional teams.
Support all Company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
Comply with U.S. FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments while maintaining positive communication and collaboration with all levels of employees, customers, contractors, and vendors.
Education Requirements Bachelor’s Degree (± 16 years) in Mechanical, Chemical, or any engineering or technical degree, or an equivalent combination of education and work experience.
Experience Details
Minimum 5 years Manufacturing engineering experience, with medical device experience required; international manufacturing experience preferred.
Strong analytical, problem‑solving, and project management skills. Six Sigma certification preferred.
Demonstrated leadership capability in team settings. Experience working in a broader enterprise/cross‑division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment, and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow‑up skills, and attention to detail.
Ability to travel approximately 25%, including internationally.
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