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.
Responsibilities: - 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 organizations 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.
Requirements: - Bachelors or higher education in Mechanical Engineering or related engineering / technology streams (Mechatronics / Polymer science / BioMedical / Plastics etc...)
- 5 7 years of relevant experience in product development and design.
- 2 3 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.