Sustaining Mechanical Engineer Jobs

Understanding of risk management principles, including the application of risk analysis techniques in the validation and use of electrical test equipment.

Assist Manufacturing Engineering with expertise in electrical design and test requirements in the development of manufacturing process instructions.

Knowledge of medical device safety standards (IEC 60601-1) is beneficial.

Experience in the validation / calibration of electrical test equipment, including familiarity with relevant standards and regulations.

Excellent problem-solving and analytical skills, with the ability to systematically solve technical problems.

Detail-oriented with a focus on quality, compliance, and attention to regulatory requirements.

Experience with quality management systems and medical device regulations

Management estimate based on product sales and average units per procedure

Support risk management activities and risk management reviews on existing products.

Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.

Provide R&D support for verification, qualification, and validation studies on existing products.

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering or related discipline, or related practical experience

Solid working knowledge of quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (e.g. FDA,.

Experience with Agile Product Lifecycle Management System is required

Understanding of documentation system and management

Preferable knowledge of Quality System Requirements (QSR), ISO 13485, TGA, PMDA, other international regulations and compliance thereof

Strong written and verbal communication skills and attention to detail

Experience in an FDA regulated environment required

2 years minimum experience in structural design engineering.

Experience in a development life cycle with substantial system responsibility.

Proficiency in computer aided design. CATIA experience preferred.

Demonstrated knowledge and ability to integrate state-of-the-art design and manufacturing methods into product concepts and designs.

Proven knowledge and application of engineering fundamentals to root cause and solve complex engineering challenges.

Demonstrated ability to manage projects with tight timing constraints.

Experience, Knowledge, Skills, And Other Requirements

3-5 year experience & advanced knowledge of business intelligence tools & processes including data mining, analyzing, modeling, visualizing.

Outstanding verbal, written communication, and presentation skills with individuals of varying roles and responsibilities cross functionally.

7-10 year experience working in global supply chains and in product based organizations.

3-5 years’ experience using ERP preferably Dynamics 365 & other suite of Microsoft products.

APICS / CPIM / CPSM certification.

Design systems and components that meet needs and requirements

Alter and modify the design to meet requirements and eliminate malfunctions

Perform a full lifecycle product development (design, develop, test prototypes, manufacture, and implement)

Conduct experiments methodically, analyze data, and interpret results

Test and evaluate theoretical designs

Identify, formulate, and produce effective solutions to emerging problems