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SYSTEMS ENGINEER II -MEDICAL

TE Connectivity
Location: Bengaluru, Experience: 5 years - 6 years
Posted On: 01-Aug-2022 | Last Date to Apply: 31-Aug-2022 | No: of Vacancies : 1

Company Profile:

TE Connectivity Ltd. is a $14 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com

Job description:

POSITION TITLE: SYSTEMS ENGINEER II

LOCATION   : Bangalore

BU               :  Medical

 

COMPANY

 

TE Connectivity Ltd., is a $13 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 78,000 employees, including more than 7,000 engineers, working alongside customers in nearly 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

 

BU / FUNCTION DESCRIPTION

 

TE’s Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic device. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world’s leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine, to sensors & connectors for surgical applications. Our innovative solutions enable groundbreaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.

 

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

MOTIVATIONAL/CULTURAL FIT

 

  • Innovation demeanor Problem solving
  • Self-development
  • Results driven
  • Clear and concise communication both locally and globally

Key Qualifications

Bachelors

Education

B.E

Industry

Manufacturing Electrical & Electronics, Mechanical

Gender Preference:

Female

Job Type:

Full Time

Diversity Tags:

Not Applicable