San Francisco Bay Area, CA
Senior Manufacturing Engineer
As a senior member of the Manufacturing Engineering team, you will be called upon to solve complex problems and implement innovative solutions. You will be a leader in providing manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. As the manufacturing engineering owner of a product line, you will work cross-functionally with engineering groups across the company, as well as with Production, Quality Control and Quality Assurance, you will resolve problems encountered on the production floor and throughout the business, and will apply your engineering knowledge and creativity to implement adaptations and modifications to the production line and to quality systems.
What Success Looks Like
- Identify strategies for improvement.
- Solve complex problems and implement innovative solutions.
- Execute detailed root cause analysis and recommend vetted solutions.
- Communicate and explain problems and solutions cross-functionally and inter-departmentally.
- Approach problems from a detail-oriented perspective.
- With a high level of customer service, provide engineering support to operations and own the process of line expansion.
- Uncover opportunities to initiate projects that directly impact yield and throughput.
- Create and maintain product and process documentation.
- Test processes, equipment, raw materials, and product and perform process validations.
- Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results.
- Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project.
- Develop specifications of a product, process, or piece of equipment.
- Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.
- Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans.
- Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation.
What You Bring
- A passion for tackling and solving technical problems.
- Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge.
- The ability to communicate complex issues in a clear, compelling manner, both orally and in writing.
- At least three years of engineering experience in a manufacturing environment (medical device experience preferred).
- The ideal candidate will also have catheter engineering experience.
- Experience with production line support.
- Also desired are knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes.
- BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline.
- Proven understanding of quality systems.