Job title: R&D/PRODUCT DVL ENGINEER II
Company: TE Connectivity
Job description: At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity’s R&D/Product Development Engineering Teams conceive original
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity’s R&D/Product Development Engineering Teams conceive original ideas for new products, introduce them into practice. They are responsible for product development, and qualification from market definition through production and release assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes conduct feasibility studies, testing on new and modified designs direct and support detailed design, testing, prototype fabrication and manufacturing ramp. The R&D/Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D/3D production drawings, product specifications, and testing requirements. They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product. Typical fields of expertise include: materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems. ROLE OBJECTIVE Role requires engineering and research skills to create, manage, analyze, and maintain the DHF, product risk management files (risk planning, risk analysis, risk mitigation, and verification of risk control implementation/effectiveness), and associated documents. In compliance with governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, ISO 14971, and you will help support product development and submission activities. RESPONSIBILITIES Provide technical support in the development of the Design History File for Combination Products including global regulatory filings, risk management, and design controls Research device clinical use, standards, and other relevant regulatory guidance for DHF content generation in support of regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and Risk Management per ISO 14971 for the device constituent and drug-device interfaces of combination products. Research industry best practices and define state-of-the-art Analyze comparable product complaints history and standards for product requirements to create robust design requirements ensuring user needs are met Partner with other functions including manufacturing, Safety/Clinical, Human Factors and Design Engineering to develop FMEAs ensuring root causes and errors are identified & mitigated provide support to risk management activities provide risk and systems engineering input to cross functional teams and to instill a spirit of collaboration throughout the organization. Supports Combination Product inspection readiness and regulatory responses as needed. Participate in focus groups in early use case development to identify unmet needs for design & engineering concept development. Support the completion of gap assessments against industry regulations or standards Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, inspection readiness. Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations by working closely with various departments including Systems, Risk Management, Safety, Clinical, Human Factors, and Design Engineering. Performs other related duties as assigned. EDUCATION/KNOWLEDGE . Bachelor’s degree in engineering, physical sciences, or technical writing with around 5+ years of experience. . Experience in risk management and design control of medical devices or combination products from concept through launch Critical Experience Basic understanding of engineering principles, system design, and risk management Experienced with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.) Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971/24971, and 21 CFR 820. Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement Proven ability to succeed in a fast-paced, challenging, and complex environment Competencies Values: Integrity, Accountability,Teamwork, Innovation
Expected salary:
Location: Bangalore, Karnataka
Job date: Mon, 09 May 2022 22:48:15 GMT
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