Project Development Specialist R&D

hace 2 días

Nuevo Laredo, Tamaulipas, México Medline Hudson A tiempo completo

General Description:
At Medline Hudson, we are seeking a talented ​​Project Development Specialist R&D to join our team. As a key member of our R&D department, you will be responsible for the development and maintenance of respiratory or other medical products. Your primary focus will be on organizing and managing multiple projects, ensuring timely completion, creating design ideas for new products, and developing creative solutions to existing products.

Responsibilities (In order of importance):
**Organization Plan and control**:

Conduct research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms.

Prepare or coordinate formal documentation of the product Designs, Risk Analysis, Product Specifications, Market Specifications, etc. according to established Product Development Procedures, and initiate formal reviews to get approved per said procedures.

Develop, maintain, and publish product Development Plans for assigned projects with critical milestones and timelines.

Coordinate the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.

Investigate and resolve technical problems involving product performance.

Coordinate the product design and development process with appropriate support departments such as engineering, regulatory, sterilization, quality, documentation, tooling, and manufacturing.

Serve as the project leader for assigned projects and be responsible for following up on all aspects of projects, including reviews with support groups and outside resources where applicable.

Prepare or follow up on the preparation of design drawings, specifications, estimates of costs, mainframe updates, etc.

Discuss and consult with Product Managers to facilitate sales or customer feedback on product requirements and specification where design or manufacturing problems are involved.

Work with manufacturing in the justification and the selection of the manufacturing process, and assign projects and establish priorities to ensure deadlines and goals are achieved.

Develop assembly methods and procedures; create engineering drawings and specifications.

Coordinate changes in process, tooling, and equipment identified to positively impact the manufacturing process, while staying within GMP guidelines.

Coordinate the reporting on project status for all responsible projects and direct reports in formal periodic project review meetings, which include cost reduction, progress, and capital spending and expense status.

Enhance growth and development through participation in education programs, current literature, training meetings, and workshops.

Participate actively in continuous quality improvement activities through compliance with safety standards.

Demonstrate professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.

**Communications**:

Ensure effective communication of changes related to their responsibilities.

Provide timely notification of situations that require immediate action.

Maintain constant communication with the rest of the members of the department and other areas.

**Relationship with employees**:

Maintain a professional and cordial relationship with members of the department, company, suppliers, and customers.

**Safety and Health**:

Establish the necessary measures to comply with the information security, industrial, and personal security procedures that the company establishes.

**Quality Systems**:

Follow the procedures established by the Quality department and comply with the company's quality system training.

**Academic/ Educational Requirements**:

Bachelor or Master of Science degree in engineering or a closely related field.

Intermediate to advance conversational English (written, read, and spoken).

**Experience/ Skills Required**:

**Technical skills**:

SolidWorks or CADD (Design and Drawing) (Desirable).

Project management.

Knowledge on ISO 13845 and related Medical regulations standards.

Knowledge in ISO and ASTM testing methods for medical devices and general plastic components.

Proficient on Microsoft Office, Adobe, and Minitab.

1+ years of experience in an engineering or quality position within the Medical device industry (Desirable).

**Interpersonal skills**:

Decision making.

Dynamic.

Ability to develop multiple projects.

Proactive.

**Tipo de puesto:**

Tiempo completo

**Lugar de trabajo:**

Empleo presencial

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