Senior Production Engineer

ZipRecruiter; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Senior Production Engineer in Pleasanton. The role involves designing and developing manufacturing processes, enhancing productivity, and complying with strict regulatory standards. Candidates should have a strong engineering background and be adept in managing complex projects within a matrixed environment.

Qualifications

• Minimum 3-5 years manufacturing engineering experience required.
• Previous medical device experience is a must.
• Strong verbal and written communication skills.

Responsibilities

• Design and develop manufacturing processes for daily production.
• Manage projects including new production equipment and process improvements.
• Support Quality Management Systems and comply with FDA regulations.

Skills

Problem Solving

Analytical Skills

Project Management

Team Leadership

Communication

Education

Bachelor's Degree in Mechanical, Chemical, Industrial or Biomedical Engineering

Tools

Gage R&R

Statistical Process Control (SPC)

Value Stream Mapping

5S

Job description

Job DescriptionJob Description

*****************LOCAL CANDIDATES TO US ONLY********NO C2C ****************************

Job title - Senior Production Engineer/Senior Specialist

Location - Pleasanton, CA (fully Onsite)

This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

MAIN RESPONSIBILITIES:

• Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians. Additional responsibilities include:
• Provide technical mentorship to engineers and technicians
• Conduct Process FMEAs and Process Validations
• Improve product quality, labor efficiency, and throughput through the use of 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; have excellent organization, problem solving, communication, and team leadership skills; work effectively with cross-functional teams
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education requirements:

Bachelor's Degree (± 16 years) 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, medical device experience required, international manufacturing experience
• Strong analytical, problem solving and project management skills. Six Sigma certification
• Demonstrated leadership capability in team settings. Experience working in a broader enterprise/cross-division business unit model . 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 communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as 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 in order to meet daily production schedules while enhancing productivity and product quality.

MAIN RESPONSIBILITIES

• Design and develop manufacturing processes, tooling, and fixtures in order 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.
• Understand manufacturing concepts like 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 as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Education requirement:

Bachelors Degree (± 16 years) Mechanical, Industrial, Chemical, Biomedical or related Engineering area or an equivalent combination of education and work experience

Experience/Background:

• Minimum 3 years Manufacturing engineering experience required. Previous medical device experience .
• Experience working in a broader enterprise/cross-division business unit model .
• 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 communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 25%, including internationally