Job Summary:

As the Manager, R&D, you will manage the design and development of next generation devices used in treatment of ENT disease.

Duties & Responsibilities:

• Manages multiple design teams in conceptualization, design, and development of medical devices through commercialization per Quality System Requirements.
• Establishes design development plans and budgets and coaches teams to execute aggressively and predictably.
• Proactively identifies and acts upon project risks and opportunities.
• Ensures that user and patient needs are translated through device design requirements, design specifications, and into verified/validated devices and procedures.
• Contributes to the identification of clinical needs and generation of Intellectual Property.
• Collaborates with Clinical, Regulatory, Quality, Manufacturing, etc. to ensure development of innovative and reliable devices that fulfill clinical needs within regulatory requirements.
• Manages development partners and other external vendors to meet project requirements and timelines.
• Coaches teams for preparation and execution of Technical, Peer, and Design Reviews.
• Directs supervision of engineers and indirect supervision of technicians.  

Qualifications:

• BS in Mechanical or Biomedical Engineering (or equivalent experience) with at least 10 years of experience in medical device Research & Development or Product Development.
• At least 3-5 years of experience managing medical device design teams from concept through commercialization.
• Direct experience generating and managing detailed project plans and budgets.
• Expertise in design, verification, and validation of medical devices including catheters and hand held surgical tools.
• Strong knowledge of state of the art materials, technologies, and processes used in the design and manufacture of catheters and hand held surgical tools.
• Experience managing external partners in development of medical devices from concept through commercialization.
• Demonstrated ability to communicate concepts, challenges, and project plans to all levels of the organization.
• Experience collaborating directly with clinicians to translate clinical, patient, and user needs into validated device designs.
• Track record of Intellectual Property generation.

Desired Qualifications:

• MS in Engineering with at least 5 years of direct experience managing development of catheters and/or hand held surgical tools.

JOB REQUIREMENTS: To apply for this position, please copy and paste the following link into your browser address bar: http://acclarent.contacthr.com/17317100