QUALIFIERS:

Successful in providing Product and Engineering Services to Medical Device majors. Specifically in NPD, Solutioning, and Medical Regulatory. A business savvy, innovative and customer facing leader would be preferred. Proven experience in setting up a Medical Device engineering team and pitching to medical device prospects.

Candidate's experience should include :

- Strong Medical Device Domain expertise and in-depth understanding of the opportunities in this outsourcing market.

- Project experience in Medical Device domains providing engineering services and solutions. Leveraging cross-functional team which include Mechanical Engineering, Embedded Software, Hardware Development and/or Electrical Engineering. With strong competency either in mechanical or embedded functional areas.

- Demonstrable understanding of ISO standards ISO13485, ISO14971, Medical Devices regulations FDA 510(k), Medical safety standard IEC 60601 and comply with them.

- Went through an FDA approval cycle and ISO13485 certification would be a plus.

- Should be experienced in Medical Device New product development and regulatory affairs.

- Ability to address field failure and end-customer usage issues with corrective actions.

- Strong Medical Devices domain competency in at least two of the following areas: Diabetes, Cardiovascular, Remote Monitoring, Therapeutic, Radiology, Hospital equipment, Bed Side equipment or Orthopedics.

Roles and Responsibilities :

- This individual will lead the Medical Device delivery team.

- Responsible for all Medical Device department operations including revenue targets and responding to RFIs and RFPs.

- Conceptualize POC's and obtain ISO13485 certification. Product Prototyping, Pilot Assembly and Design Transfer to Production.

- Ownership for the complete product development. Defining service offering, pulling the team and labs together and delivering to customer requirements.

- Hire, mentor and lead a competent cross functional engineering team with strong medical device domain expertise.

- Build strong competency in Quality Assurance and Regulatory Affairs consulting. Compilation of product Technical File, DHF, DMR for regulatory submissions.

- Adhering to Quality Management System and product development process as per ISO13485 requirements.

- Provide technical guidance and Program Manage all medical device design and engineering projects and successfully deliver on time, within budget. By professionally managing customer scope and program risks with effective project planning, monitoring & delivery and decision making. Continuous monitoring of project progress/milestones and review with top management.

- Build solutions leveraging innovative technologies to address medical device pain points for target markets: Initially USA, India and later Europe.

- Interact with and develop eco-system partners: Regulatory, Hospitals, Doctors, Medical Industry Experts panel.

Candidate Qualifications :

- BE degree in Mechanical, Embedded or Biomedical, engineering from a reputed college

- 15+ years relevant experience with last 8+ years in the Medical Device industry

- Ability to build a team of 100+ associate and managing them would be an added advantage.

Candidate's Ability :

- Excellent attention to detail

- Creative with innovative ideas

- Strong verbal and written communication skills with an ability to deal with peers, leadership and customers alike

- Excellent time and project management skills

- Results orientated, self-motivated, resilient and able to perform under pressure.

- Flexible and open-minded, whilst being able to challenge and be challenged.

- Commercially astute with an awareness of industry trends, new technologies and research areas.

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