Sr. Manufacturing Engineer
is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Company is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.
location: San Jose, California
job type: Permanent
salary: $100,000 - 135,000 per year
work hours: 9am to 5pm
As a Sr. Manufacturing Engineer, this individual is responsible for maintaining and scaling existing production lines including resolving line down scenarios and identifying and implementing continuous process improvements. The position will be responsible for on-demand production line support, define manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixture and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities.
Core Job Responsibilities:
- Provide daily support to troubleshoot and resolve manufacturing production issues following GMP and company Quality Management System.
- Identify root cause of operational failures and support Corrective and Preventative Action plans by provide solutions using problem-solving skills including Fishbone, 5 Whys or Pareto Charts.
- Define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation.
- Design, document, assemble, qualify and release custom and off the shelf manufacturing and testing tooling, fixtures and equipment. Create and release associated maintenance and calibration procedures.
- Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.
- Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, standard operating procedures and equipment/fixture specifications.
- Generate production metrics including yields, scrap rates, capacity/bottle necks and cycle times and routinely present to management.
- Other manufacturing engineering duties or support as assigned or requested.
Required Knowledge/Skills, Education, And Experience:
- B.S degree in Chemical, Mechanical, Biomedical Engineering or
- 5+ years experience as design or manufacturing engineer supporting product development or production lines. 3+ years with an advanced degree.
- Experience with GMP/GDP is required
- Experience with manufacturing equipment design and development is required
- Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.
- Understanding of statistical methods is required
- Solidworks Experience is required
- Proficient with standard business software (MS Office, Excel, Outlook etc.)
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
Preferred Knowledge/Skills, Education, And Experience:
- Experience with sterility assurance is preferred
- Prior experience in medical device or other highly regulated industry is preferred.
- Agile PLM experience is preferred
- Understanding of engineered materials and fabrication methods is preferred
- Experience with reprocessing and sterilization of reusable medical devices, especially those with long lumens, is preferred
skills: Work Environment:
This position operates in a decontamination and sterilization manufacturing environment using contaminated medical devices potentially exposing the employee to blood borne pathogens and related health hazards. This role requires the use of varying levels of personal protective equipment (including, gowns/bunny suits, masks/face shields, gloves, foot protection, and safety glasses). This role involves routinely working in a controlled environment room (CER). 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.
- Must be able to lift a minimum of 40 pounds and perform repetitive bending and lifting motions over a period of time.
- Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)
- 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.
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.