Senior Engineer- Design Quality

35377

At Terumo Blood and Cell Technologies, our 8,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

JOB TITLE: Senior Design Quality Engineer

JOB SUMMARY

This position represents the quality organization as an integral team member on development projects for medical devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control process and procedures and ensure maintenance of Quality Records for the design and development of the products. They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

This individual performs routine functions which require application of standard techniques, procedures, and criteria in carrying out a sequence of related engineering tasks. Using prescribed methods, performs specific and limited portions of a broader assignment of an experienced Engineer. Duties are assigned to provide experience and familiarization with Design Control regulations and requirements, engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• 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

OTHER DUTIES AND RESPONSIBILITIES

• 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

• work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Additional projects assigned as needed

MINIMUM QUALIFICATION REQUIREMENTS

Education

• 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.

Experience

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

Skills

• 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

-Or-

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

PHYSICAL REQUIREMENTS

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.

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