R&D Engineer 2

Position Summary

Principal Responsibilities

1.    Develop, identify, experiment, conduct and coordinate validation, verification of proposed materials/ packaging or finished products to ensure their quality and functionality
2.    Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development.
3.    Own and execute technical deliverables within the project as required.
4.    Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations (Internal/External) and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables as per the design control procedure. 
5.    Document all new ideas for products and/or processes which should be assessed for intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement 
6.    Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles.
7.    Accountable/responsible for creation of project and product DHF/DMR documentation.
8.    Create and update Project Charters, project plan, use of project management template for execution and tracking on a required basis by manager.
9.    Accountable and responsible for NC’s/CAPA’s & R&D Investigations, Business Documents, Design Control and D&D Plans.   
10.    Support for LANSA, DSD, Labelling, IFU and Quantum related activities.
11.    Develops and/or coordinates the V&V plans and activities for new and existing products.
12.    Works with the team to solve complex technical issues that clear obstacles to ensure successful project delivery.
13.    Works across R&D development teams for SMEs and additional resource support by project/phase.
14.    Manages product development, compliance and improvement project to meet end user, marketing and regulatory needs.
15.    Conduct statistical analysis for process stability monitoring & seek opportunity of cycle time and productivity improvement using process capability study (Cpk), Design of Experiment (DOE), Statistical Process Control (SPC) tools etc.
16.    Works with Global Procurement, Operations, and external vendors to ensure development of a robust high value product supply chain and to identify opportunities to improve.
17.    Develops assembly methods and procedures; creates engineering drawings and specifications. 
18.    Develops and maintains project plans with detailed schedules and critical milestones, risks, resource loading and budgets. Maintains timely project plan data in appropriate data systems and reporting dashboards.
19.    Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable. 
20.    Demonstrates professional responsibility by collaborating with other personnel to achieve department goals while fostering an enjoyable environment. 
21.    Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
22.    Support technical file preparation, regulatory submissions and audits as required. 
23.    Prepares formal documentation of the product designs, risk analysis, product specifications, etc. according to established product development procedures.   
24.    Lead and participate in design and technical phase reviews.
25.    Any other assignment / task as deemed required to meet project deliverables.

Education / Experience Requirements

Qualification    :    
Must have an undergraduate degree in a related engineering/material science field, graduate or advanced degrees strongly preferred.

Experience    
a)    Talented and ambitious to learn and get things done
b)    The candidate has an engineering background in Medical Technology, packaging, plastic, or chemical engineering. Ideally some relevant work experience in manufacturing, Quality Assurance, engineering, or Product Development related to Medical Device Industry. Candidates with an engineering background in electronic or mechanical education are preferred.
c)    Relevant work experience (Fresh graduate or till 2 years: P1) and 2-4 years: P2 and P3) in relevant manufacturing Industry will be considered.
d)    Good skills with computers and standard software as well fluid English skills in oral and written are a must. 
e)    Strong analytical and problem-solving skills.
f)    Effective verbal and written communication skills.
g)    Team player with good interpersonal skills.
h)    Proficient in Microsoft Office, Minitab and others computerized analysis applications
 i)    Self-motivated, high energy, positive attitude with initiative and drive for timely completion of goals.
 j)    Able to travel domestically and internationally

Specialized Skills / Other Requirements