Job Description

Description

Senior Engineer - Product Testing

Phillips-Medisize, a Molex company, is looking for a senior product testing engineer having independent responsibility in setting up and executing Test procedures for leading all activities related to Design Verification of the medical devices for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for.

About the Position
The Product testing engineer will be part of a product team that has product designers developing complex electromechanical medical devices like autoinjectors for use by the patients. The individual will also be responsible in maintaining Lab equipment, work with Design engineers to help build Test fixtures/assemblies and assisting with overall Lab logistics.

Responsibilities:

Lead/Execute, perform, summarize, and report out System verification test activities

Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.

Understand the product functionality and perform the Functional and Performance testing for the product.

Lead/Support and perform Design Verification activities

Drive/Perform Installation/Operational/Performance Qualification Protocols

Develop Test instructions and Test protocols.

Follow instructions clearly from Design engineers during Test execution.

Support Design engineers in Test fixture creation, building up & tearing down Test equipment.

Plan Lab logistics and maintain the material supply for testing requirements.

Diagnose, isolate, and investigate problem reports and defects.

Support to work with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports

Ensure good documentation and Good Manufacturing practices are followed in the Verification Process

Experience in IEC basic safety, EMI-EMC standards

Interacts with design team to resolve tests-related technical issues.

Presents the findings / objective evidence and able to present with rationale with applicability / exclusions

Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

Leadership Competencies:

Willing and able to learn a new technology on your own but know when to seek out help from experts.

Identify the root cause of complex problems and solve them by determining the most appropriate fix.

Hold yourself accountable and deliver on commitments.

Desire to help improve patient's lives and will hold yourself accountable to the rigors of developing solution for medical devices.

Demonstrate accountability for your decisions and can articulate rationale without being defensive. View mistakes as learning opportunity and support an environment of continuous improvement.

Enjoy coaching others on test system development and can provide constructive feedback to improve other's implementations and designs.

What we are looking for in you:
You have a strong leadership profile and are result oriented. You are not afraid to take lead in complex discussions or hands-on execution. At the same time, you are open for input from colleagues, have a team-oriented mentality and can get the best out of your team. From previous experience, you know how to uphold the required level of quality in a fast-paced environment. Being accustomed to complex situations and processes, you work and think independently and are self-motivated. You have a flexible approach and in critical situations you walk the extra mile and show the way.

Professional Qualifications

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Industrial Engineering, or related field

Overall, 5 to 10 yrs. of experience with minimum 3 years in System Verification testing and performance testing.

Hands on experience in overall final design verification/validation (V&V) testing of medical products.

Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.

Understanding of test methods and processes as well as the methods used to verify product in the areas of mechanical, electrical, functional testing environments.

Basic hands-on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data

Experience in Tools like Minitab (Data Analysis) / ALM (test Environment) etc.

Understanding of hardware and software product design methodologies and test practices.

Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems

Basic understanding of FDA, MDD/MDR, ISO and IEC design control procedures, regulations, and standards.

We offer you

• A challenging position in an international innovative and successful company in growth.
• An opportunity to setup the processes and development team in India to support the global and Indian customers.
• An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India.
• Well-structured training and continuous development of your competencies.
• Exciting career possibilities within the constantly growing area of medical devices
• Salary on a competitive level.

The Company - In Short

Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region.