Project Engineering Manager

Location: Cincinnati, OH
Department: Research & Development
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2018-125
Office based or Remote: Office Based

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

Position Summary:

The Engineering Project Manager contributes to the development of ablation products that treat atrial fibrillation.  Job performance requires management of cross-functional team activities, thorough knowledge of medical device development methodologies, and excellent communication skills. This position will have product development engineers reporting to them.  Deliverable outputs include quality completion of on-time, on-budget projects, as well as development of the engineering team.  This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-lead products through positive patient outcomes.

 

Roles and Responsibilities:

  • Manage cross-functional project team activities including technology, development, schedule, resource utilization, budget, and performance validation.
  • Generate and manage overall development planning tools including critical specifications (Design Plan, Quality Plan, etc.), management tools (Project Schedule, Tooling / Part / Fixture tracking forms, V&V matrix, etc.) and communication tools (Weekly meeting template, team norms, etc)
  • Develop, communicate, and complete action items to maintain ownership and accountability across project team.
  • Develop a rapport with key customers – surgeons, nurses, and other clinicians
  • Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products.
  • Manage the role assignments, work plans, priorities, performance, and development plans of direct reports.
  • Create and maintain programmatic and technical documentation to insure efficient planning and execution.
  • Align and coordinate resources, priorities, work plans, and activities among outside suppliers and the AtriCure Product Development group.
  • Communicate with and direct external suppliers of components, subassemblies and finished assemblies.
  • Generate and document intellectual property.
  • Review and authorize engineering design changes.
  • Develop component and product technical specifications including the integration and consideration of applicable standards and regulations.
  • Mentor other engineers.

 

BASIC QUALIFICATIONS:

  • BS degree in Engineering (mechanical, electrical or biomedical preferred) and 7+ years experience in medical device R&D.
  • 5+ years of management experience (combination of project management and direct report management)
  • Knowledge of Design Controls and experience with FDA QSR 21 Part 820 and ISO13485
  • Understanding of complete development horizon including needs assessment, Voice of the Customer, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation.
  • Track record of:
    • Detailed program management exhibiting comprehensive planning and thorough communication.
    • Using MS Project to schedule and manage complex development projects.
    • Creative problem solving, troubleshooting and use of formal root-cause analysis techniques.
  • Strong engineering skills and active participation in the technical advancement of the programs.
  • Proficiency in leading integrated process teams, as well as coordinating and communicating customer requirements.
  • Excellent written and oral communication skills.
  • Ability to read technical specifications, blueprints, and drawings.

PREFERRED QUALIFICATIONS:

  • PMP certification preferred
  • MS degree in a technical field or equivalent is preferred.
  • Experience in managing the development of capital equipment as well as single-patient use disposables.
  • Experience in PMA and 510k device development.

 

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):

  • This position is in an office / lab environment.
  • Position involves periods of working at a desk / on a computer for extended times.
  • Position will involve working in a lab environment with tissue.
  • Position will involve approximately 20% travel

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.

AtriCure has a variety of benefits available for US based employees and their families.  Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more.   Corporate-based employees also have full access to our on-site fitness center and cafeteria.  To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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