Production Engineer In Medical Device Company

Job Title: Engineer

Location: A medical device client in Singapore

Department: Engineering

Reports to: Engineering Manager

Position Summary:

My client is seeking a highly skilled and innovative Engineer to join our team in the medical device industry. The Engineer will be responsible for designing developing and improving medical devices ensuring compliance with regulatory standards and supporting the manufacturing process.

Key Responsibilities:

• Design and Development:
  • Design and develop medical devices from concept to production.
  • Create detailed engineering drawings specifications and prototypes.
  • Conduct feasibility studies and testing to validate design concepts.
• Product Improvement:
  • Identify and implement improvements to existing products.
  • Collaborate with crossfunctional teams to enhance product performance reliability and manufacturability.
  • Use design for manufacturability (DFM) and design for assembly (DFA) principles to streamline production.
• Regulatory Compliance:
  • Ensure all designs and processes comply with relevant regulatory standards (e.g. ISO 13485 FDA).
  • Prepare and maintain technical documentation for regulatory submissions.
  • Participate in internal and external audits to ensure compliance with quality systems.
• Manufacturing Support:
  • Provide engineering support to the manufacturing team.
  • Troubleshoot and resolve technical issues that arise during production.
  • Develop and implement process improvements to enhance manufacturing efficiency and product quality.
• Testing and Validation:
  • Develop test protocols and conduct testing to ensure product safety and efficacy.
  • Analyze test data and document results.
  • Perform root cause analysis and implement corrective actions for product failures.
• Project Management:
  • Lead and manage engineering projects ensuring they are completed on time and within budget.
  • Develop project plans timelines and budgets.
  • Coordinate with crossfunctional teams to ensure project success.
• Innovation and Research:
  • Stay uptodate with advancements in medical device technology.
  • Conduct research to identify new technologies and materials that could enhance product performance.
  • Innovate and propose new product ideas and improvements.

Qualifications and Skills:

• Education:
  • Bachelors Degree in Mechanical Engineering Biomedical Engineering Electrical Engineering or a related field.
• Experience:
  • Minimum of 35 years of experience in engineering preferably in the medical device industry.
• Skills:
  • Strong knowledge of medical device design and development processes.
  • Proficiency in CAD software (e.g. SolidWorks AutoCAD).
  • Excellent problemsolving and analytical skills.
  • Strong project management and organizational abilities.
  • Effective communication and teamwork skills.
  • Knowledge of regulatory standards (e.g. ISO 13485 FDA).
• Certifications:
  • Relevant professional certifications (e.g. PMP Six Sigma) are a plus.

Working Conditions:

• Fulltime position.
• Office and laboratory/production floor environment.
• May require occasional travel and overtime including weekends and public holidays.

Competitive

Remote Work :

No