Senior Engineer, Product Transfer

hace 3 semanas

Tijuana, México Stryker A tiempo completo

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: 

Who We Want

Strategic thinkers. People who enjoy analyzing data or trends for planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What You Will Do

Execute engineering activities for product transfers and/or new product and process introductions within the designated project, ensuring compliance with Stryker procedures and thorough documentation of all activities.

Ensure the quality of processes and products as defined in the appropriate operation and material specifications specific to the project.

Assist in the selection of components and equipment based on analysis of specifications, reliability, safety, and regulatory requirements relevant to the project.

Participate in or support capital acquisition activities within the project scope, including specifying equipment, installation, and validation.

Analyze equipment to establish operating data, conduct experimental tests, and analyze results, participating in process review meetings related to the project.

Capable of generating PFMEA, Control Plans, Work instructions, and relevant manufacturing documents specific to the project.

Generate PPAP associated with product transfers and launches within the project framework.

Perform process capability studies specific to the project requirements.

Generate in-process and subsequent inspection documentation within the context of the project.

Conduct MSA studies for new products and new processes within the project parameters.

Provide training for manufacturing team members within the project scope

Ensure adherence to GMP and safety procedures within the project framework.

Interact with global teams as necessary to support project objectives

Capable of presenting to local management level within the project scope

Perform all other duties as assigned within the context of the project

Education level and special training required

Bachelors degree in an engineering discipline

Six Sigma Yellow belt or higher certification

Valgenesis or other related validation control software certification

Work experience required

4+ years of experience as Sr. Engineer on new product introduction or product transfer roles

Experience at a highly regulated industry such Automotive, Aerospace or Medical device

Qualification and skills

Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project required

Bilingual: English & Spanish

Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment

Experience in an FDA regulated or regulated industry

Experience of GD&T, process mapping, statistical methods and process/product validations

Experience in executing/reporting EQ, OQ, PQ

Change management experience with regulated system

Develop Work instructions

Experience with DOE

Experience on DFM

2D CAD skills

Minitab

Internal PPAP

Capable to develop MVP

SAP - master data

Experience with MES

Fixture design/proposal with Poka Yoke

Root cause analysis techniques

Layout Design

Value stream mapping

About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at 

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