Job Summary

This position requires highly talented and passionate individual to help us identify and implement innovative solutions to
address the medical device industry needs. The candidate will be responsible for developing and implementing new
product designs, product improvements and clinical evaluations. This position also requires candidates to explore
their medical writing skills for clinical and regulatory documents for medical devices. The role will mainly focus on creating
Clinical Evaluation Plans/Reports (CERs), with future additional for development of other clinical evidence documents as
part of the Medical Device Regulation and Medical Device Directive.

The preferred candidate will have strong technical medical device understanding, excellent written and oral skills, and
leadership abilities. This candidate should possess a strong capability to interpret design and development related
documents, functional and performance testing, biocompatibility and risk analysis with respect to federal safety
regulations, quality policies, best practices and procedures through trainings.

Responsibilities:

Provide thorough technical understanding and engineering support for design and development activities for
new and existing products.
Organize and conduct medical and technical writing of clinical evaluation reports (CERs) in support of
compliance to EU MDR- Med Dev 2.7, rev 4.
Support medical writing efforts for post-market clinical follow up (PMCF) plan generation and summary (clinical
evaluation reports).
Work cross-functionally to ensure adherence to submission and company-driven deadlines.
Providing product guidance and expertise to conduct literature searches on products/product families.
Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from
literature; collect and summarize primary data to support risk assessment.
Conduct proofreading, editing, document formatting, review comment integration and document
completion/approval activities.
Write detailed technical reports based on design verification analysis/testing for design changes and product
design activities.
Understand test methods which specify measurement equipment, test set-up, measurement systems analysis,
and data analysis which will go as a part of CER.

Desired Qualifications:

Post Graduate / Doctorate in Engineering (Biomedical Engineering, Material Science or a closely related
engineering degree required)
Strong interpersonal skills
Excellent technical judgment.
Strong communication skills
Demonstrated accountability for successful completion of designated tasks.
Team oriented.
Understanding of disciplined product development processes and quality requirements.

Job Location- PUNE