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Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Supports design and development of product changes for disposable medical devices
- Lead and support small to medium-sized projects with global cross-functional teams in the implementation of design changes
- Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools
- Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings
- Develop and execute test method validations, product testing, and verification/validation activities
- Build prototypes and models and may operate machine tools, design and build basic tooling, test fixtures and assembly equipment
- Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance
Requirements
What you’ll need- Bachelor's degree in Mechanical, Plastics, Biomedical Engineering or a related field; advanced degree is a plus
- 3+ years of related experience in Class II or Class III disposables medical product development
- Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
- Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks)
- Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
- Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements
- Strong attention to detail, organized, and able to independently manage multiple priorities
- Ability to read, write and comprehend English
- Design for Six Sigma (DFSS) training or certification (preferred)
Benefits
Comp & perks- Medical, dental and vision coverage that start on day one
- Basic life, accident, short-term and long-term disability insurance
- Business travel accident insurance
- Aon Pooled Employer Plan (401(k) retirement savings plan)
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays and paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
mechanical engineeringplastics engineeringbiomedical engineeringdesign history file documentationtest method validationsproduct testingverification/validation activitiesprototypingCADPDM enterprise software
Soft Skills
initiativelearninginnovationattention to detailorganizationindependent managementmulti-priority management
Certifications
Design for Six Sigma (DFSS)
