Job Description

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.) in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

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. *

• Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required. *

• Facilitate cross-functional coordination to implement changes and improvements to operational systems and processes, with knowledge and consideration towards requirements and inputs from cross-functional teams and key stakeholders. *Coordinate project risk management to successful completion of tasks and activities, appropriately escalating issues to management or leadership, as required. *

• Approach problems from a detail-oriented perspective. *

• Suggest independent recommendations for project approach, scope, and tactics. *

• 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.

• Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project. *

• Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans. *

• Participate in project planning and scheduling. *

• 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

Position Qualifications

Minimum education and experience:

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

Additional qualifications:

• 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

• High degree of accuracy and attention to detail

• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Location and Salary

• Alameda, CA ($95,000 to $127,000)

Working Conditions

• General office, laboratory, and cleanroom environments

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds

• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

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