Manufacturing Engineering Manager, Instrument
As a manufacturing engineering manager, the individual will lead the manufacturing engineering team for new product development and design transfer; support manufacturing continuous improvement and scale up, for internal and external manufacturing lines. Provide leadership to recruit, direct, and manage manufacturing engineers and technicians. Responsible for department quality, performance metrics and budget.
location: San Carlos, California
job type: Permanent
salary: $142,000 - 180,000 per year
work hours: 9am to 5pm
Develop plans and milestones for manufacturing engineering and manufacturing deliverables to support and adhere to development program schedule.
- Establish a reporting system that monitors project status, cost targets, DFM initiatives, 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.
- 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.
- Design and release production equipment, fixtures and testing equipment as needed to build the production line internally or as needed at suppliers. Release preventive maintenance and calibration procedure for equipment control.
- Lead continuous improvement projects to improve assembly touch time, production efficiency, and reduce cost.
- Plan and execute lean manufacturing implementation and manufacturing scale up
- Lead and support nonconformance investigation and failure analysis 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, and develop manufacturing engineers and technicians.
Required Knowledge/Skills, Education, And Experience
- BS degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or equivalent. MS preferred.
- Minimum 12 years' experience in manufacturing engineering with focus on design transfer and manufacturing continuous improvement. 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 manufacturing, design transfer, DFM and process development and best practice for instrument or catheter production.
- 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.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
skills: This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.
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.