Job as Technical Lead in Perfint Healthcare - alpconsulting

Perfint Healthcare is a world leader in planning and targeting solutions for image guided interventional procedures - with an emphasis on oncology and pain care. Perfint’s products are installed at some of the world’s top hospitals and are CE marked.

Post: Technical Lead

Job Description:
The Technical Lead/Lead Architecture will be responsible to understand clinical requirement and conceptualize and design a solution that meets the clinical requirement. S/he shall also own clinical evaluation and regulatory certifications to bring the product to market.
Job Responsibilities

In coordination with the product manager create the product requirement document
Develop V&V and Regulatory strategies along with respective functional leaders
Develop the design requirements and assign them to a team of design and development engineers (to develop a medical optics solution)
Review and authorize design concepts for development
Review and authorize module level test results for system integration
Own system integration and testing of the solution (assisted by V&V team)
Own clinical validation / clinical trials along with the clinical evaluation team
Own regulatory & safety compliance and certification including design control documentation, constructing technical files etc (assisted by regulatory team)
Own research papers / white papers / clinical study papers with collaborating institutions (assisted by product management team)
Own product cost roadmap and transfer to manufacturing
Own system / field problem resolution till product stabilizes

Candidate Profile:
10 years of product development experience with atleast 3 years as an Architect / Lead Systems Designer.
Exposure to medical industry standards and regulatory like USFDA, CE, SFDA, PMDA, ISO13485 etc
Mandatory: Demonstrable experience in meeting complex multi-disciplinary product performance requirements, complex algorithms design and implementation.
Proficiency in data analysis packages such as SPSS/MATLAB, Programming skills
Strong leadership, communication and people development skills

Additional Information:
Experience: 3-10
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 15th May, 2013