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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in disposable medical device development, including design changes, product testing, and compliance with FDA regulations. Proficient in CAD design, risk management, and engineering problem-solving with a focus on continuous improvement.
Highest-signal resume keywords
BS In Mechanical EngineeringDesign For Six Sigma CertificationUnderstanding Of FDA Design ControlsWorking Knowledge Of CAD DesignExperience In Class II Or Class III Medical Products
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Support design changes and product development for disposable medical devices within sustaining engineering and new product development
- Support R&D projects involving new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation
- Identify, investigate, and solve engineering problems using 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
- Support and execute test method validations, product testing, and verification and validation activities
- Build prototypes and models
- Operate machine tools and design and build basic tooling, test fixtures, and assembly equipment as needed
- Adhere to design control procedures, safety rules, company policies, FDA and international regulations, and guidance
Requirements
What you’ll need- BS in Mechanical, Plastics, Biomedical Engineering or a related field; MS preferred
- 0–2+ years of related experience in Class II or Class III disposables medical product development
- Design for Six Sigma (DFSS) training or certification preferred
- Understanding of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
- Working knowledge of CAD design and PDM enterprise software, such as Creo or Solidworks
- Understanding of FDA Design Controls and ISO 13485 Quality Management Systems
- Understanding of ANSI/AAMI/ISO 14971 Medical Devices risk management
- Takes initiative with a high aptitude for learning, innovation, and continuous improvements
- Strong collaboration, verbal and written communication skills
- Strong attention to detail, organized, and able to independently manage multiple priorities
- Ability to read, write and comprehend English
Benefits
Comp & perks- Discretionary bonuses
- Medical, dental and vision coverage starting on day one
- Basic life, accident, short-term and long-term disability, and business travel accident insurance
- Aon Pooled Employer Plan (Aon PEP)
- 401(k) retirement savings plan
- Investment options, financial education, and retirement resources
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- 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
- Flexible workplace policy
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Product DevelopmentDesign History File DocumentationTest Method ValidationPrototypingInjection MoldingExtrusionUltrasonic WeldingSterilizationRisk ManagementCost Reduction
Soft Skills
Strong CollaborationVerbal CommunicationWritten CommunicationAttention To DetailOrganizational Skills
Tools & Technologies
CreoSolidworksPDM Enterprise SoftwareMachine ToolsTest Fixtures
Certifications & Qualifications
Design For Six Sigma Certification
Industry Keywords
Disposable Medical DevicesISO 13485 Quality Management SystemsANSI/AAMI/ISO 14971CAPANCR