Sustaining R&D Engineer – Medical Devices
Overview
Principal Engineer at Actalent leads design changes and product improvements for disposable medical devices. This role drives innovation in life-sustaining technologies and enhances patient outcomes globally.
What You'll Do11
- 1Lead the design and development of product improvements and sustaining engineering initiatives for disposable medical devices
- 2Manage engineering projects from concept through implementation including timelines budgets and deliverables
- 3Serve as technical expert on design changes involving materials suppliers labeling CAPA/NCR remediation and cost reduction projects
- 4Investigate complex technical challenges using risk-based engineering principles and customer-focused solutions
- 5Apply engineering tools such as dFMEA Human Factors Engineering statistical analysis and CAD to support product improvements
- 6Create and maintain Design History Files ensuring compliance with FDA Design Controls ISO standards and international regulations
- 7Partner with global cross-functional teams across R&D Quality Manufacturing Regulatory and Supply Chain
- 8Ensure adherence to FDA Design Controls and ISO Quality Management Systems
- 9Mentor engineers and technicians while contributing to innovation initiatives patent disclosures and intellectual property development
- 10Lead cross-functional engineering initiatives with project management experience
- 11Support CAPA NCR remediation and product lifecycle management activities
Requirements10
- 1BS in Mechanical Plastics Biomedical Engineering or related field with MS preferred
- 25+ years of medical device development experience especially with Class II or Class III disposable products
- 3Strong expertise in plastics materials injection molding extrusion ultrasonic welding UV/solvent bonding sterilization processes
- 4Deep understanding of FDA Design Controls and ISO Quality Management Systems
- 5Proficiency with CAD and PDM software such as Creo or SolidWorks
- 6Knowledge of medical device risk management standards and methodologies
- 7Ability to apply human factors engineering and risk management tools like dFMEA
- 8Project management experience leading cross-functional engineering initiatives
- 9Experience supporting CAPA NCR remediation and product lifecycle management activities
- 10Passion for continuous improvement innovation and implementing best practices
Salary Insight
$104 - $156k per year
Location
Required Skills
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