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.
- 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.
- 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.