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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.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
engineering principlesdesign verificationdesign validationrisk managementDFMEAUFMEAstatistical analysisCAD modelingmechanical systemsfluid dynamics
Soft Skills
collaborationcommunicationproblem-solvinganalytical thinkingattention to detailtechnical report writingproject managementinterpersonal skillsadaptabilitycritical thinking
Tools & Technologies
SAPAgile PLMMinitabSolidWorksDesign History Files (DHF)Device Master Records (DMR)ISO 13485FDA 21 CFR 820process validationquality systems
Certifications & Qualifications
BS in EngineeringISO 14971
Industry Keywords
medical device designmanufacturingregulated industryplastic processinginjection moldingDesign for Manufacturability (DFM)vascular access devicesverification and validationrisk managementcompliance requirements
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