Sr. Engineer- Design Quality

Artech L.L.C.; Thiruvananthapuram; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Artech L.L.C. in India seeks a Design Quality Engineer to support medical device development, ensuring compliance with QMS and design control, and maintaining design history files for product development.

The role involves reviewing documentation, conducting audits, supporting design changes, and assisting in the transfer of designs to manufacturing, with emphasis on data integrity and regulatory compliance. Strong English and collaboration skills are essential.

Qualifications

• Bachelor's degree in engineering or equivalent qualification.
• Experience in a regulated medical/dev environment is preferred.
• Solid understanding of ISO standards and design controls.
• Strong written and verbal English communications.

Responsibilities

• Supports product design changes and new product development with the development team.
• Ensures compliance to QMS and design control processes and procedures.
• Reviews and approves documentation for product releases and designs.
• Interprets and recommends modifications to documents as appropriate.
• Reviews changes to verify accuracy of DHF, risk files and traceability reports.
• Performs DHF audits and supports design transfer activities.
• Analyzes data for post-market monitoring and risk management.
• Communicates effectively within cross-functional teams.

Skills

Self-starter

Planning skills

Detail oriented

Communication skills

Regulatory knowledge

Team collaboration

Continuous learning

Analytical thinking

Education

Bachelor's degree or equivalent

Bachelor of Science Degree in Engineering

Job description

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.

Experience

• 5 to 12 years of experience within a regulated industry, medical/pharma experience preferred

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, executes and recommend 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 recommend modifications to documents where appropriate

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

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

• Bachelor's 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.

-Or-

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