19 Nov 2016

Manufacturing Engineer II

Posted By : Dev Kumar

NOTE: This job listing has expired and may no longer be relevant!

Job Description


Job Description:

The Manufacturing Engineer will be responsible for planning and execution of projects, interface with project core team and/or cross functional teams. Projects are defined as product sustaining/improvement/expansion programs, cost reduction programs, procurement of machinery, validation of new equipment and materials, quality integration projects and facilities expansion projects.

Key Responsibilities:

Provide Manufacturing Engineering support to Manufacturing and other departments in Operations. Interface with project core team or cross functional team to complete manufacturing engineering deliverables.
Participate in equipment and process validation projects. Facilitate or execute the project plan. Release process documentation and coordinate training of production personnel on processes.
Create, review and complete engineering documentation such as part and assembly drawings, BOMs, engineering specifications, product requirements, test protocols and reports, technical reports, ECR’s, ECO’s, deviation, manufacturing procedures, design review, etc.
Establish/review/update manufacturing work and test instructions, methods sheets and other assembly aids for use by production personnel to assemble, mix, test, label or package finished goods for single use devices or capital equipment.
Develop process parameters for new equipment. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
Optimize processes for yield improvements, cycle time improvements, and scrap reduction.
Implements Lean manufacturing concepts to eliminate non-value added activities.
Perform root cause analysis and provide problem solving for manufactuing issues.
Participate in product development project to ensure that the project team is designing for manufacturability in the development phases of the project. Coordinate design/process transfer on new products into manufacturing.
Perform any other duties assigned by Manager.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the client's Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Management Requirements


A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field.
Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.
General knowledge of other related disciplines, business unit function and cross group dependencies/relationships.
This job is the fully-qualified career-oriented position.

Problem Solving:

Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Has a broad knowledge of a variety of alternatives and their impact on the business unit.

Planning and Organization:

Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities.
Plans and organizes project assignments and maintains project schedules.

Discretion/Latitude; Supervision Received; Decision Making:

Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.
Interprets, executes and recommends modifications to company policies.
Assists in establishing departmental policies and procedures.
Work is reviewed upon completion for adequacy in meeting objectives.

Business Relationships and Project Management:

Establishes and cultivates a wide range of business relationships to facilitate completion of assignments.
May interact with vendors.
Participates in determining goals and objectives for projects.
May lead projects within the function or department and/or represents a specialized field in larger project teams.
Influences middle management on business solutions.


Contributes to the completion of specific programs and projects.
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.


Represents organization as a prime contact on contracts or projects.
Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.
Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.


Participates in the development of less experienced staff by setting an example, providing guidance and offering counsel.


Shift: Business 1st Shift (08:00:AM – 04:30:PM)
Duration: 6 months
Territory: CA-Bay Area


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