Senior Engineer- Design Quality

are assigned to provide experience and familiarization with Design Control regulations and requirements, engineering methods, independent thinking, and company practices and policies.

• Supports product design changes and new product development projects, working closely with the development team
• Ensures compliance to QMS and design control processes and procedures
• Reviews and approves documentation that supports product releases
• Interprets, execute and recommends modifications to documents where appropriate.
• Reviews Document changes to verify accuracy and completeness, including Technical Files, clinical data, risk management files, and traceability reports.
• Confirms objective evidence for product development efforts is present and filed within the DHF
• Performs audits of data integrity among Design History Files
• Creates draft risk management documentation for medical device products
• Performs DHF Audits prior to and after Design Transfer
• Analyses data for post market monitoring and risk management
• Interprets, executes, and recommends modifications to documents where appropriate

• Work assignments may require additional development and a maturing of in-depth engineering skill(s) or breadth to eventually include Reviews and approves new or revisions of protocols/operating instructions specific to the project Reviews and approves testing, project experiments and analysis of data along with reports Reviews and approves design verification and design validation protocols and reports
• Reviews and approves new or revisions of protocols/operating instructions specific to the project
• Reviews and approves testing, project experiments and analysis of data along with reports
• Reviews and approves design verification and design validation protocols and reports
• work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Additional projects assigned as needed

• Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

• Minimum 5 years of experience within a regulated industry, medical/pharma experience preferred

• Write and speak fluent English required
• Shows initiative as a self-starter to complete tasks as assigned required
• Planning skills to prioritize and execute multiple projects required
• Detail oriented required
• Willing to seek guidance while carrying out instructions furnished in written or verbal form and takes task approach to ensure assignments are accomplished according the guidelines and schedules required
• Demonstrated desire to continually learn and keep up with changing technology
• Knowledge of protocols, and statistical tools, preferred
• Possess ability to apply fundamental techniques and latest principles of technology to develop and enhance projects
• Ability to comprehend in depth knowledge of product design and process development specific to the project
• Able to work cooperatively and effectively in a team environment to achieve common goals and results
• Knowledge and use of relevant PC software applications and skills to use them effectively
• Knowledge of ISO standards desired
• Demonstrated ability to communicate effectively both verbally and in writing

An equivalent competency level acquired through a variation of these qualifications may be considered.

As per Indian regulation.

Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala.

As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad.

Our high-quality products touch the lives of patients in over 80 countries across the world.

True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture.

Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning.

People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.

Job Segment: R&D Engineer, Quality Engineer, Product Development, Senior Quality Engineer, Medical Device, Engineering, Research, Healthcare