Overview
On Site
Full Time
Skills
Project Management
SAFE
Documentation
Training
GDP
GLP
Preventive Maintenance
Test Equipment
Continuous Improvement
Test Methods
Optimization
Cost Reduction
Quality Improvement
DV
IQ
OQ
Accountability
Research and Development
System Requirements
Intellectual Property
Higher Education
Mechanical Engineering
Streaming
Mechatronics
Science
Biomedicine
Medical Devices
QMS
Program Management
Communication
Leadership
Collaboration
Management
Product Development
Regulatory Compliance
Job Details
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:
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 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 / 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.
- bility to influence stakeholders and work across functions.
- Experience managing technical projects and cross-functional teams.
- Familiarity with product development and compliance processes.
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