SR R&D/PRODUCT DVL ENGINEER

Job Overview

TE Connectivity’s R&D/Product Development Engineering Teams conceive original ideas for new products, introduce them into practice. They are responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp. The R&D/Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D/3D production drawings, product specifications, and testing requirements. They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product. Typical fields of expertise include: materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems.

What your background should look like:

This role is a critical element between product/process development and operations to ensure effective transition. This position requires a blend of technical expertise, leadership skills, project management, and innovative thinking to drive manufacturing excellence and process optimization. The location for this position will be at San Rafael, Costa Rica.

Key Responsibilities

• New Product/Process Development
• Execute process and test method validation along with design, develop, and qualify tooling/equipment
• Using problem solving and DMAIC tools to solve processes and process improvements
• New Product Introductions
• Manage product transfers from new product development to operations or product transfers from site to site.
• Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers.
• Team Leadership (Primary)
• An effective communicator that prepares status reports, modifies schedules, and manages project plans.
• Communicate to stakeholders, customers, and others informed of project status and/or related issues
• Ability to coordinate a team of engineers and technicians and direct technical work
• Coach/mentor technical topics to junior engineers and technicians during product transfers
• Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.
• Project Management (Supporting)
• Manage project timelines and resources effectively.
• Work with cross functional teams while being self-driven
• Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones
• Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines
• Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly
• Manage design requirements like Bioburden or Particulates, Biocompatibility and Cleanroom Environment compatibility

 

WHAT YOUR BACKGROUND SHOULD LOOK LIKE

• Required Skills & Experience

• Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• 7+ years of engineering experience
• 5+ years of working experience in the Medical Device Industry
• 3+ years of working experience in new production development or product transfers
• Thorough understanding of Quality Management Systems (QMS) requirements that involve:

1. Process Mapping
2. Manufacturing Process Instructions
3. DOE and Process Characterization
4. OQ/PQ Protocol and Reports
5. IQ/OQ Protocols and Reports
6. PFMEAs
7. MVP/MVRs.

• Experience in technically leading a team of engineers and technicians across multiple projects
• Medical Device New Product Development which includes process development and characterization along with equipment/fixture design and qualification and test method and process validations

• Preferred Skills & Experience

• Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion
• Experience with design controls, FDA regulation, GMP practices, and QSR requirements
• CAD proficiency - SolidWorks and Mastercam
• MS Office proficiency
• Ability to achieve goals with effective planning and prioritization skills to meet immediate and long-range needs with independence
• Must be well-organized, detail-oriented, with excellent oral and written communication skills

Competencies