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Engineer 2 – Sustaining, R&D
TeleflexEngineer 2, Sustaining responsible for lifecycle management and product quality in medical device industry. Collaborating with teams to ensure regulatory compliance and manufacturing efficiency.
About the role
Key responsibilities & impact- Assist in analyzing market segments and competitive products to understand product positioning and identify areas for improvement.
- Support product evaluations and clinical interactions to understand user needs, device applications, and clinical workflows.
- Provide engineering support for product demonstrations, basic clinician interactions, and product troubleshooting.
- Apply engineering principles to evaluate product design changes, ensuring compliance with regulatory and quality standards.
- Contribute to design verification and validation activities, including developing test protocols, executing tests, and analyzing results.
- Assist in risk management activities, including DFMEA, UFMEA, and hazard analysis, under the guidance of senior engineers.
- Support design documentation, including updating Design History Files (DHF) and Device Master Records (DMR), ensuring compliance with ISO 13485 and FDA 21 CFR 820 requirements.
- Collaborate with process development teams to ensure design outputs are compatible with manufacturing requirements and scalability.
- Participate in sustaining engineering activities such as troubleshooting product performance issues, implementing design improvements, and ensuring manufacturability.
- Work with regulatory teams to ensure product changes and updates meet compliance requirements.
- Support the execution of process validation studies (IQ, OQ, PQ) and contribute to process control improvements.
- Assist in root cause analysis, CAPA (Corrective and Preventive Actions), and non-conformance resolution efforts.
- Develop familiarity with SAP, Agile PLM, and quality systems to support engineering changes, product tracking, and documentation management.
- Engage in technical report writing, including summarizing test data, engineering analysis, and change justifications.
- Contribute to product labeling verification, documentation updates, and engineering change requests (ECRs) as part of sustaining efforts.
- Collaborate with supply chain and operations teams to ensure smooth implementation of design changes and material substitutions.
- Participate in technical discussions, cross-functional meetings, and project team collaborations to support business objectives.
Requirements
What you’ll need- BS in Engineering, or equivalent technical discipline.
- Minimum of 2 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
- Basic understanding of mechanical systems, fluid dynamics, and material properties related to vascular access devices.
- Familiarity with CAD modeling (SolidWorks) and ability to create and modify 3D models and 2D drawings.
- Awareness of Design for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design.
- Understanding of verification and validation principles, including ISO 14971 risk management.
- Ability to perform basic statistical analyses using Minitab or equivalent software.
- Exposure to design control processes and regulatory requirements, including ISO 13485 and FDA 21 CFR 820.
Benefits
Comp & perks- Health insurance
- Flexible work arrangements
- Professional development
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
engineering principlesdesign verificationdesign validationrisk managementDFMEAUFMEAstatistical analysisCAD modelingmechanical systemsfluid dynamics
Soft Skills
collaborationcommunicationproblem-solvinganalytical thinkingattention to detailtechnical report writingproject managementinterpersonal skillsadaptabilitycritical thinking
Certifications
BS in EngineeringISO 14971