Manufacturing Engineer II, Instrument
As a Manufacturing Engineer, NPI, Instrument the individual participates in product development phases and support continuous improvement in the production line. The position will be responsible for process and fixture/tooling development to support both new product development and sustaining for the existing manufacturing line.
location: Redwood City, California
job type: Permanent
salary: $79,000 - 107,000 per year
work hours: 8am to 5pm
Core Job Responsibilities:
- Design, document, qualify and release manufacturing process and assembly equipment, fixture and process aids.
- Conduct process DOE to optimize process windows and perform process capability analysis.
- Provide product and process DFM (Design for Manufacturing) input to product development core team to enhance manufacturability and reduce product cost.
- Support manufacturing assembly line, release and/or refine BOMs, work flow processes and detailed MPI work instructions.
- Provide training to production staffs for assembly, testing, and the use of released equipment, methods and procedures.
- Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure, disposition of non-conforming materials, and etc.
- Perform failure analysis for discrepant production components, assemblies or field returns, and troubleshoot manufacturing line issues.
- Other manufacturing engineering duties or support as assigned or requested.
Required Knowledge/Skills, Education, And Experience
- BS degree in Mechanical, Industrial, Chemical, Biomedical, Materials Engineering or equivalent experience is required.
- 2+ years experience as design or manufacturing engineer supporting product or production lines.
- Strong knowledge in Solidworks, prototyping, tooling/fixture development
- Experience in materials, process development, BOM structure and best practice for flexible instrument or catheter devices is preferred.
- knowledge and hands on experience with process validation planning/execution, IQ/OQ/PQ protocols and reports is preferred.
- Working knowledge and experience in creating PFMEA, process control plan, SPC, or other statistical analysis tools for MFG assembly lines.
- Agile PLM experience is preferred
- Ability to manage multiple priorities in fast-paced environment.
- Prior experience in medical device or other highly regulated industry is preferred.
- knowledge of 21 CFR part 820 and ISO 13485
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.
skills: 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.