Director Project Management - AtriCure, Inc. - Minneapolis, MN

Director Project Management - AtriCure, Inc. - Minneapolis, MN -

AtriCure, Inc. is a medical gadget firm and a pacesetter in creating, manufacturing and promoting revolutionary cardiac surgical ablation methods designed to create exact lesions in cardiac tissue for the remedy of atrial fibrillation, or AF, and techniques for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting AtriCure’s ablation merchandise for the remedy of AF throughout concomitant open-coronary heart surgical procedures and sole-remedy minimally invasive procedures. AF impacts greater than 16 million individuals worldwide and predisposes them to a 5-fold elevated danger of stroke. The FDA has not cleared or accredited sure AtriCure merchandise for the remedy of AF or a discount within the danger of stroke.

POSITION SUMMARY:
The Project Management Director will report back to the Sr. Director of Product Improvement in our ablation franchise. This particular person will contribute to the corporate success by means of the management of cross-useful group actions and efficiently bringing medical merchandise to market. This individual can be a topic-matter-professional in challenge management practices and supply management in challenge management execution. This place may have product improvement engineers and probably extra junior challenge managers reporting to them. This place contributes in a collaborative means with management, undertaking groups, manufacturing associates, exterior distributors and different work teams to realize the corporate’s objectives of manufacturing market-lead merchandise by means of constructive affected person outcomes.

ROLES AND RESPONSIBILITIES:

• Handle cross-useful challenge group actions together with know-how, improvement, schedule, useful resource utilization, finances, and efficiency validation.


• Generate and handle general improvement planning instruments together with essential specs (Design Plan, High quality Plan, and so forth.), management instruments (Project Schedule, Tooling / Half / Fixture monitoring varieties, V&V matrix, and so forth.) and communication instruments (Weekly assembly template, workforce norms, and so forth.)


• Develop, implement, and pollinate greatest-practices strategies for undertaking management inside product improvement groups.


• Create, keep, and instill program/venture and technical documentation practices to insure environment friendly planning and execution.


• Handle the position assignments, work plans, priorities, efficiency, and improvement plans of direct studies.


• Develop a rapport with key clients – surgeons, nurses, and different clinicians.


• Develop in-depth understanding of medical procedures and methods relevant to AtriCure merchandise.


• Align and coordinate assets, priorities, work plans, and actions amongst outdoors suppliers and the AtriCure Product Improvement group.


• Decide work procedures, put together work schedules, and expedite workflow.


• Talk with and direct exterior suppliers of elements, subassemblies and completed assemblies.


• Generate and doc mental property.


• Evaluation and authorize engineering design modifications.


• Develop element and product technical specs together with the mixing and consideration of relevant requirements and laws.


• Mentoring of different challenge managers and engineers.

BASIC QUALIFICATIONS:

• BS diploma in Engineering (mechanical, electrical or biomedical most popular) and 15+ years expertise in medical system R&D.


• 10+ years of challenge management expertise.


• Topic Matter Skilled in Design Controls, FDA QSR 21 Half 820, and ISO13485


• Requires experience in full improvement horizon together with wants evaluation, Voice of the Buyer, know-how improvement, element design & manufacturing methods improvement, regulatory necessities, and product verification / validation.


• Requires monitor document of detailed program management exhibiting complete planning and thorough communication. Expertise utilizing MS Project to schedule and handle complicated improvement tasks.


• Requires robust engineering expertise and lively participation within the technical development of the packages.


• Have to be proficient appearing in and main built-in course of groups, in addition to coordinating and speaking buyer necessities.


• Capable of handle cross-practical workforce actions together with know-how improvement, schedule, useful resource utilization, danger mitigation, price range, and efficiency validation


• Wonderful written and oral communication expertise.


• Expertise with knowledge evaluation, drawback-fixing, troubleshooting and formal root-trigger evaluation methods.


• Means to learn technical specs, blueprints, and drawings.


• Confirmed monitor report of producing and documenting mental property.


• Able to prioritizing duties and supply a well timed schedule of completion.

PREFERRED QUALIFICATIONS:

• PMP certification most popular


• MS diploma in a technical area or equal is most popular.


• Expertise in managing the event of capital gear in addition to single-affected person use disposables.


• Expertise in PMA and 510okay system improvement.

ESSENTIAL JOB FUNCTIONS (Bodily or psychological qualification requirement – i.e. stroll, sit, stand, bend, push/pull, carry (how a lot), journey %):

• This place is in an workplace / lab setting.


• Place includes durations of working at a desk / on a pc for prolonged occasions.


• Place will contain working in a lab setting with tissue.


• Place will contain roughly 20% journey

All certified candidates will obtain consideration for employment with out regard to race, colour, faith, intercourse, nationwide origin, age, protected veteran standing or standing as a person with incapacity.

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