In this role, you have the opportunity to
Lead NPI with R&D engineering, Quality engineering and Procurement to develop and transfer new products and manufacturing processes from development to production.
You are responsible for
- Developing, documenting and implementing assembly processes, including equipment, fixtures, tooling etc…
- Performing process characterization studies with DOEs, and validate equipment with Installation, Operational and Process Qualifications.
- Managing procurement of automation equipment and coordinating with contract manufacturer on requirements and acceptance testing.
- Writing work instructions and design / model associated tools and fixtures.
- Integrating product design into PLM system – BOMs, Manufacturing Operations, Device History Records
- Participating in project teams in support of development activities and ensuring tasks are completed and meet established time-frames
- Arranging production line layout and balancing workflow
You are a part of
Our dynamic Advanced Manufacturing Engineering team that works cross functionally across our IGTD product lines. Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.
To succeed in this role, you should have the following skills and experience
- BS in physics, engineering or biomedical engineering or equivalent experiencerequired
- Requires 5+ years’ experience in functional area or related area
- Medical device industry experiencepreferred
- Familiar with medical device product and process Validation: IQ, OQ, PPQ, PQ
- Knowledge and experience with Medical Safety regulations from the FDA, IEC, AAMI, IEEE, and ISO
- Experience with formal problem solving techniques
- Good working knowledge of electrical, mechanical designs
- Strong working knowledge and experience with SolidWorks application
- Knowledge of proper English usage, grammar, spelling, vocabulary and of generally accepted office practices, procedures and equipment
- Proficient in the use of Project Management tools for planning, scheduling, task estimation
- Advanced Microsoft Office skills, Excel: Forms, Formulas, Functions, Pivot Table, & Graphs; PowerPoint: Graphics & Animation; MS-Project: Project planning, tracking
- Agile or Windchill experience with ECO writing/review preferred
- Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates
- Strong attention to details
- Adhere/respond to established time frames and schedules