Biomedical Device R&D Engineer

• Design class-3 implantable neuro-stimulation devices in new start-up a
• Exciting opportunity to involve in innovative medical device design an

Job Responsibilities

The Biomedical Device R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of company’s neuro-stimulation devices. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing.

• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Perform Verification and Validation (V&V) and may draft protocols/reports for approval.
• Work with engineers & QA to create new components, assemblies, or tools.
• Conducts testing to verify that the design meets the engineering specifications.
• Document engineering work in compliance with the company's quality system.
• Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Compiles and analyzes data, identifies causes, draws conclusions, generates reports.
  
  
  

Job Requirements

• Engineering degree desired or equivalent experience in related job field
• Preferred 2+ yrs Biomedical product or medical device development experience
• Working knowledge FDA regulated medical device design controls a plus.
• Ability to work independently and good problem-solving skills
• A team player with great inter-personal skills and strong sense of ownership
• Good command of English and Chinese
• Fresh graduates are welcome.
• Candidate with more experience will be considered as senior engineer
  
  
  

Company Overview

We are an innovative and energetic startup in the medical device industry, driven by a passion for transforming healthcare through cutting-edge technology. Our team consists of highly experienced professionals with a proven track record in medical device development, ensuring the highest standards of innovation and quality. If you are looking to join a forward-thinking company where creativity and expertise come together to make a real impact, this is the place for you!

We invite you to be a part of the design team.

Job Types: Full-time, Permanent

Pay: $20,000.00 - $60,000.00 per month

Benefits

• Additional leave
• Flexible schedule
• Gym membership
• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development
  
  
  

Schedule

• Monday to Friday
  
  
  

Supplemental Pay

• Performance bonus
• Yearly bonus
  
  
  

Education

• Bachelor's Degree (Preferred)

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