Lead Engineer, Quality Engineering, Systems Engineer

Job Description

Onsite Engineer plans, leads, reviews and front-ends Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development.

• Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools.
• Demonstrates good project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
• Develops and maintains good rapport with business leaders, other internal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
• Reviews the deliverables to ensure completeness, accuracy and appropriateness of the design output / test executed and ensure its compliance to Good Documentation Practices.
• Provides training to the team on GDP/GLP, IQ/OQ process, Calibration & Preventive maintenance activities and ensures the quality of deliverables.
• Involves in the review / creation of DV Protocols and provides valuable inputs in terms of test equipment selection, capability / accuracy, sample size optimization, acceptance criteria definition, etc.
• Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported / led, keeps a track on the self-utilization.
• Seeks for continuous improvement through value propositions (e.g. test method optimization) by identification of possible opportunities for time reduction / cost reduction / quality improvement.
• Promptly follows-up with stakeholders for review / approval / signatures of project artifacts (including Memos, MSA, DV Protocol & Reports, IQ/OQ Protocols & Reports etc).
• Quality System accountability:
  Maintains all relevant Protocols, Procedures, Reports and Records to ensure strict compliance of R&D functional operation to meet the Quality System requirements.
• Provides cross-functional coordination based on project needs.
• Supports the organization s intellectual property strategy by documenting data and independent, unique and patentable ideas that result from experimentations.
• Performs any other tasks (like Sustaining Engineering / New Product Development activities), as assigned.

• Bachelor s or higher education in Mechanical Engineering or related engineering / technology streams (Mechatronics / Polymer science / Bio Medical / Plastics, etc...)
• 57 years of relevant experience in product development and design.
• 23 years of experience specifically in medical devices/products.
• Proven track record in leading cross-functional teams through QMS and regulatory product development processes.
• Demonstrated success in project or program management.
• Strong communication and leadership capabilities.
• Ability to influence stakeholders and work across functions.
• Experience managing technical projects and cross-functional teams.
• Familiarity with product development and compliance processes.

• Mid-Senior level

• Contract

• Pharmaceutical Manufacturing

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