Manufacturing Engineer

Overview Join to apply for the

Manufacturing Engineer

role at

Haemonetics .

Manufacturing Engineer is responsible for providing project management and engineering support for medical products (both Liquid Solutions and Disposables) which are primarily located at external contract manufacturing (CM) partner's facilities at SEA / APAC / Europe. The engineer will be collaborating with cross-functional teams and stakeholders, both internal and external to Haemonetics, and providing engineering solutions to solve manufacturing process, component availability & change control management.

Responsibilities

Drive SCN / ECO deliverables from Initial stage to closure & manufacturing implementation.

Generate, review and reject or approve SCN / CAF / ECO / test protocols / reports.

Generate Agile ECO SPN (Specification Package Notification) to external contract manufacturers.

Perform OH stocks, Production Impact date, Last Time Buy analysis for EOL components.

Perform presentation to cross region, cross functional teams & route DR for approvals in Agile.

Review / update manufacturing working instruction / BOM in Agile system.

Work closely with Haemonetics R&D, Quality, Sourcing, RA and contract manufacturers to solve or de-risk manufacturing day to day challenges.

Able to document and report activities with appropriate amount of precision with data driven mentality.

Carry out any other duties and responsibilities as assigned by supervisor.

Qualifications

Bachelor's or master's degree in Mechanical, Biomedical, Chemical Engineering or equivalent.

2-3 years of experience in Manufacturing, Quality, or Engineering; fresh graduates are encouraged to apply.

Candidates with experience and knowledge in one or more of the following areas will be given strong consideration :

Familiarity with the Agile system and related methodologies.

Proficiency in basic statistical tools, as well as experience with Six Sigma and LEAN manufacturing principles.

Experience in the development and / or production of Class I, II, or III medical devices.

Comprehensive understanding of medical device manufacturing standards, including but not limited to :

Good Manufacturing Practice (GMP)

Process Validation and Verification

Process Failure Mode and Effects Analysis (PFMEA)

Risk Management and development of Control Plans

Gauge Repeatability and Reproducibility (GR&R)

Design of Experiments (DOE)

First Article Inspection (FAI)

Preparation and execution of IQ / OQ / PQ protocols and reports

Statistical Process Control (SPC) and Process Capability Analysis

Application of Six Sigma methodologies for problem-solving

Location : Penang, Malaysia.

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