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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in mechanical medical device development, including prototyping, design for manufacturability, and compliance with regulatory standards such as ISO 13485 and FDA requirements. Strong collaboration skills are essential for working with cross-functional teams and external partners.
Highest-signal resume keywords
Mechanical Medical Device ExpertisePrototyping SkillsDesign For ManufacturabilityISO 13485 FamiliarityGood Documentation Practice
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Mechanical EngineeringBiomedical EngineeringProduct DesignFunctional Product DesignTest Method DevelopmentDesign ControlRegulatory ComplianceProduct Specifications DevelopmentManufacturing TransferVascular Access Devices
Soft Skills
Excellent Communication SkillsCollaborationCross-Functional Teamwork
Tools & Technologies
Paperless PLM System
Industry Keywords
Interventional DevicesAdvanced Diagnostic CathetersTherapeutic CathetersComplex Delivery SystemsRegulatory FrameworksClinical Study Locations
About the role
Key responsibilities & impact- Contribute to customer-specific product development projects from concept freeze through detailed design development and transfer to manufacturing
- Work in areas of interventional devices, including vascular access devices, advanced diagnostic and therapeutic catheters, and complex delivery systems
- Collaborate in cross-functional and international teams with program managers, design and process engineers, prototyping specialists, RA/QA representatives, external business partners, and customers
- Develop and build prototypes at the conceptual drafting stage and hands-on
- Develop complete product specifications and work with suppliers on purchasing specifications
- Develop test methods and perform tests to characterize design and process outputs
- Ensure full and compliant documentation in the paperless PLM system according to regulatory frameworks, standards, and industry best practices
Requirements
What you’ll need- Bachelor’s degree in a scientific or engineering discipline with a focus on Mechanical, Plastics, or Biomedical Engineering; an advanced degree is preferred
- Strong technical expertise in mechanical medical devices, applied materials, functional product design, design for manufacturability, and prototyping
- 3 years of experience in the interventional device industry preferred
- Excellent communication skills in English, both written and spoken
- Familiarity with Good Documentation Practice, Design Control, ISO 13485, and FDA requirements
- Willingness to travel occasionally to customers or clinical study locations worldwide
Benefits
Comp & perks- Professional development support
- Career development opportunities, depending on the role, location and operational conditions