Manufacturing Engineering Manager

  • location: Redwood City, CA
  • type: Permanent
  • salary: $145,000 - $165,000 per year
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job description

Manufacturing Engineering Manager

job summary:
Overview:

As a manufacturing engineering manager, the individual will participate in product development core team as the manufacturing engineering lead. Provide leadership to recruit, direct, and manage manufacturing engineers and technicians. Responsible for manufacturing pilot line planning, set up, and prototype builds. Lead and oversee process development, validation and design transfer activities. Responsible for planning and directing the layout of work stations, equipment, workflow, assembly methods, and manufacturing resource utilization. Implement and manage continuous improvement principals for manufacturing pilot lines and production. The role has budgetary and staffing responsibility for the department.

 
location: Redwood City, California
job type: Permanent
salary: $145,000 - 165,000 per year
work hours: 9am to 5pm
education: Masters
 
responsibilities:
- Provide technical leadership to ensure new devices are optimally designed for manufacturability, and with acceptable manufacturing, inspection and testing processes.

- Develop plans and milestones for manufacturing engineering and manufacturing deliverables to support and adhere to the program schedule.

- Establish a reporting system that monitors project status and cost targets, and communicate them to the project team and upper management in a timely manner.

- Plan and set up manufacturing pilot lines, work stations, process flow, and assure capacity (both manpower and facilities) and quality production of new products.

- Design and release production equipment, fixtures and testers as needed to build the production line internally or as needed at suppliers. Release preventive maintenance and calibration procedure for equipment control.

- Lead and contribute to process FMEA development and risk management strategy. Develops process control plan to minimize risk to product. Review and provide feedback to BOM structure, and manufacturing routers.

- Collaborate with supply chain, R&D and quality to develop supplier landscapes to ensure supply quality and launch readiness.

- Lead continuous improvement projects to improve assembly touch time, production efficiency, and reduce cost.

- Direct work flow to ensure MFG pilot line builds at the highest achievable quality level and efficiency, and maintain Good Manufacturing Practices in accordance with FDA regulatory requirements.

- Establish and ensure manufacturing systems are adequate to supply current and future control and information required by all areas of the business (i.e. cost, inventory, productivity, yield, scrap, rework etc.).

- Hire, train, develop, and review manufacturing engineers and manufacturing personnel

 
qualifications:
- BS degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or equivalent. MS preferred.

- Minimum 12 years experience in manufacturing engineering with focus on new product introduction and design transfer. MS degree with 8+ year experience is also considered

- Minimum 5 years in people and project management

- Strong knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity

- Strong technical skill in materials, process development, BOM structure and best practice for rigid instrument assembly

- Ability to read and interpret detailed mechanical drawings and communicate technical information. CAD experience with 3D modeling tools is a plus

- Proven ability to recruit top engineers and motivate the team.

- Experience in resource and budget planning.

- Agile PLM experience is preferred

- Ability to manage multiple priorities in fast-paced environment.

- Prior experience in design control process and medical device industry is required.

- Excellent Project Management skills. Experience in Agile product development is a plus.

- Excellent knowledge of 21 CFR part 820 and ISO 13485

 
skills: - BS degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or equivalent. MS preferred.

- Minimum 12 years experience in manufacturing engineering with focus on new product introduction and design transfer. MS degree with 8+ year experience is also considered

- Minimum 5 years in people and project management

- Strong knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity

- Strong technical skill in materials, process development, BOM structure and best practice for rigid instrument assembly

- Ability to read and interpret detailed mechanical drawings and communicate technical information. CAD experience with 3D modeling tools is a plus

- Proven ability to recruit top engineers and motivate the team.

- Experience in resource and budget planning.

- Agile PLM experience is preferred

- Ability to manage multiple priorities in fast-paced environment.

- Prior experience in design control process and medical device industry is required.

- Excellent Project Management skills. Experience in Agile product development is a plus.

- Excellent knowledge of 21 CFR part 820 and ISO 13485


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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