Manufacturing Engineer - Contract
Company: Atlantic Partners
Location: Irvine
Posted on: January 24, 2023
Job Description:
Responsibilities:
- Develops, evaluates, and improves manufacturing methods. Writes
assembly procedures for new products and revises assembly procedure
for existing products. Confers with Quality Engineering
representative and incorporate appropriate quality checkpoints in
assembly procedures.
- Support Design Transfer of new products from R&D to
Production (including OQ/PQ) by leading and documenting
Manufacturing Design Reviews, and Prototype and Pilot Builds.
Writes and reviews production-related items for FMEA/Hazard
Analysis. Identifies, designs and develops production and test
tooling and fixtures.
- Provide Engineering support to CPI (Continuous Product
Improvement). Screens waivers, CAPA items, material failures, etc.
to identify candidates for ECO. Researches corrective action,
writes Project Requests, makes clear recommendation (redlines) to
drafters, and directs and supports V&V testing (including
reporting) as necessary.
- Trains manufacturing employees on the use of all applicable
manufacturing process documentation and procedures.
- Analyzes and plans work force utilization, space requirements,
and workflow, and designs layout of equipment and workspace for
maximum efficiency and FDA/OSHA compliance. Manages equipment
maintenance program and writes equipment process and product
validation protocols and reports.
- Provide Facilities support for the service, security, and
maintenance of the building. Monitor health and safety risks to
employees.
- Confers with vendors to develop product specifications and
arrange for purchase of equipment, materials, or parts, and
evaluates product according to specifications and quality
standards. Performs IQ/OQ/PQ of equipment as required.
- Identifies, designs, and develops production tooling, test
tooling and fixtures. Utilizes SolidWorks design software in those
design efforts.
- Estimates production times, staffing requirements, and related
costs to provide information for management decisions.
- Confers with management, engineering, and other staff regarding
manufacturing capabilities, production schedules, and other
consideration to facilitate production processes and maximize
efficiency while ensuring quality.
Requirements:
- BS Manufacturing Engineering/Mechanical Engineering Masters
degree a plus; five plus years related experience and/or training
in the medical device manufacturing industry; or equivalent
combination of education and experience. Must be able to
demonstrate experience in Design Transfer and writing assembly
procedures for medical device production. Must be able to
demonstrate project management experience.
- To perform this job successfully, an individual should have
knowledge of Design software (SolidWorks), Manufacturing (MRP)
software, Project Management software, Statistical software,
Spreadsheet software, and Word Processing software.
Keywords: Atlantic Partners, Irvine , Manufacturing Engineer - Contract, Engineering , Irvine, California
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