Manufacturing Engineer II (Medical Device | 13485 | Metals

Specific Duties and Responsibilities

As assigned by a project team leader or a manager, as self-identified, or as business needs dictate, independently perform any of the following:

• 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 interdepartmentally. *
• Approach problems from a detail-oriented perspective. *
• Suggest independent recommendations for project approaches, scope, and tactics.*
• Support production;
  Creating and maintaining product and process documentation;
  Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput. *
• Demonstrate an understanding of quality, operational, and financial systems, company products, and customer requirements and how the product or project impacts the objectives of the business. Demonstrate an understanding of how other functional groups within the company are impacted by projects at hand and can impact the project or product results.
• Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixtures on the production line. Perform equipment qualifications. *
• Test processes, equipment, raw materials, and products. Perform process validations. Author protocols to execute tests, 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*
• Participate in project planning and scheduling*
• Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation*
• Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.

* Indicates an essential function of the role

Minimum education and experience:

Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree with 1+ years relevant engineering experience, or an equivalent combination of education and experience

• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Excellent written, verbal, and interpersonal communication skills required
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required

Alameda, CA

$95,000 to $127,000

• General office, laboratory, and clean room environments.
• Willingness and ability to work on site.
• Business travel from 0% - 10%
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is…