Product Engineer

Merit Medical Singapore Pte. Ltd; Região Norte; Presencial; BRL 120 000 - 190 000; Tempo integral

Resumo da oferta

Merit Medical Singapore Pte. Ltd in Singapore is seeking a Biomedical/Mechanical/Electrical Engineer to lead design change controls and sustaining engineering for critical care products, ensuring validation to customer and regulatory requirements.

The role applies CAD (SolidWorks) and statistical methods to resolve design issues and maintain design history files. Stay current with technologies to advance product capability while ensuring compliance with international standards.

Qualificações

• Degree in Biomedical/Mechanical/Electrical Engineering.

Responsabilidades

• Validate/verify product design per customer requirements.
• Manage sustaining engineering project costs.
• Report progress and deviations from plans.
• Coordinate development with packaging, process, and other departments.
• Maintain up-to-date knowledge by attending meetings and reviewing literature.
• Assist in addressing customer dissatisfaction with a product.
• Support cost reduction programs and provide technical support for existing products.
• Establish knowledge of customer requirements through literature and visits.
• Comply with local, state, federal, and Merit safety regulations/policies.
• Engage in other assigned projects.

Conhecimentos

Regulatory compliance

Sustaining engineering

Problem solving

CAD Design

SolidWorks

Quality Assurance

Formação académica

Biomedical/Mechanical/Electrical Engineering degree

Ferramentas

SolidWorks

CAD Design

Descrição da oferta de emprego

The incumbent will be responsible for the design change controls and product sustaining engineering initiatives. He/She shall ensure that the product designs are validated per customer requirements, including domestic and international regulatory standards.

Utilize technical, project and leadership skills in the development, improvement and optimization of critical care products such as transducers and catheters. Apply technical principles, theories and concepts, as well as problem solving capabilities to resolve product design issues. Maintain design history files, determine test methods requirements, design verification, perform failure mode effect analysis and implementproduct-related solutions that improves performance and/or quality, as well as address shelf-life requirements.

Provide technical support for existing products with issues relating to regulatory compliance, customer complaints, process improvement and CAPA resolution.

Keep abreast of potential new technologies to enable thedesign of new materials and capabilities. Leverage existing technologies to advance our core businesses while supporting the development of new products.

ESSENTIAL JOB FUNCTIONS

• Participate in Product Engineering efforts to validate /verify product design per customer requirements.
• Manage cost of sustaining engineering projects assigned.
• Make timely reports of progress, noting deviations from time or cost plans or customer design requirements.
• Coordinate development efforts with packaging engineering, process engineering, and all other departments that participate in product development.
• In own field of scientific / engineering competence, maintain up-to-date familiarity with developments through attendance at professional meetings, literature and consultations.
• Assist in anticipating, answering and alleviating any customer dissatisfaction with a product.
• Support cost reduction programs and provide technical linesupport for existing product lines.
• Establish / maintain a base of knowledge of customer requirements through literature, customer visits, etc.
• Comply with all local, state, federal, and Merit safety regulations / policies / procedures.
• Comply with all quality policies / procedures / practices through consistent application of sound Quality Assurance principles.
• Other projects as assigned.

JOB SPECIFICATIONS

• Degree in Bio-Medical / Mechanical / Electrical Engineering.
• Minimum 3 years’ experience of product / process engineering in a medical device company or related industry.
• Experience in product design with thermoplastic knowledge, preferably in medical device industry, will be an advantage.
• Knowledge in CAD Design / SolidWorks and statistical methods.
• Excellent interpersonal and communication skills