לוח משרות דרושים מהנדסים עבודה זמנית

n this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:

QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams

We are looking for a talented R&D Mechanical Engineer to join our innovative medical device company.
In this role, you will be responsible for developing surgical and transcatheter devices to help cardiovascular patients, you will understand the need and the operating environment (anatomy and Cath lab) as well as the ability to thrive in a collaborative team environment.
If you are passionate about making a difference in the lives of patients and thrive in a fast-paced, dynamic environment, we would love to hear from you!
What will you do?
Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles.
Generate work instructions, test methods, engineering models and drawings/prototypes, etc, to establish/characterize product and/or process specifications.
Create/update more complex design control documents including requirement specs, and risk documents.
Develop and execute engineering project plans.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Evaluate input and form a technical recommendation including designing parts, components and subsystems.
Train, coach, and guide lower level employees on routine procedures.

Develop and implement the business plans and model for consumables, processes, and procedures.

Manage inventory levels and consignment products availability and forecast at the customers sites.

Define, develop, and implement business planning processes and forecast models.

Coordinate and manage cross-functional teams to improve business planning methods.

Assist in preparing strategic plans by analyzing trends and forecasts.

Maintain in-depth knowledge of market dynamics, market share, demographic trends, and growth projections.

Work closely with the field engineers and the customers representatives to better understand the trends and forecast.

Determine and execute key business initiatives to drive business operations and support Landas business model.