Senior Sustaining Engineer
4 weeks ago
Mantell Associates is partnering with a leading Medical Technology firm to find a Senior Sustaining Engineer to support their growing team.
Key Responsibilities:
- Lead engineering activities to ensure product support throughout the commercialized life cycle
- Provide engineering expertise for design and process changes of existing products, including change control documentation
- Develop and implement solutions for complex problems, considering business objectives and cost implications
- Design and develop manufacturing processes, tooling, and fixtures to meet business needs
- Support equipment qualifications, process verification, and validation studies
- Ensure process documentation and validation for manufacturing transfer and scale-up
- Develop and update work instructions, workmanship standards, and process documents
- Monitor and assess manufacturing process performance and address emerging issues
- Provide engineering support for non-conforming products, customer complaints, and CAPAs
- Support continuous improvement of manufacturing operations for quality, productivity, and cost savings
Requirements:
- Bachelor's degree in Mechanical or Biomedical Engineering (or related field)
- 5-8 years of experience in medical device development, production, or regulated industry
- Experience with ISO 13485 and FDA Quality System Regulations
- Knowledge of statistical evaluation software and Lean Six Sigma principles
- CAD experience (preferably SolidWorks)
- Strong project management skills and ability to prioritize multiple projects
- Cross-functional team player with excellent engineering and problem-solving skills
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, please contact us.
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