Senior Engineer, Advanced Operations

hace 3 días

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.

**Who we want**
- ** Detail-oriented process improvers.** Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
- ** Self-directed initiators. **People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- ** Dedicated achievers. **People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- ** Collaborative partners. **People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

**What you will do**

Stryker’s Instruments Advanced Operations team is seeking to hire a Senior Engineer, Advanced Operations to work on new product introduction process in Tijuana, Mexico. This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products. This role is located on-site in Tijuana, Mexico and will support new product introductions into the state-of-the-art manufacturing facility from various Stryker franchises.

**Roles & Responsibilities**:

- Provide engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker product procedures
- Collaborate with global sites utilizing both English and Spanish documentation to lead design transfer activities for new product launches into the Tijuana manufacturing plant.
- Ensure quality of process and product as defined in the appropriate operation and material specifications
- Assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements
- Support capital acquisition activities
- Analyze equipment to establish operating data, conduct experimental test and result analysis and participate in process review meetings
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches
- Complete capability studies for in process inspection and generate subsequent Inspection documentation
- Conduct validation and MSA studies for new products and new processes
- Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
- Author, review, and approve validation documentation
- Drive and execute effective communication with all stakeholders to enable project success
- Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
- Lead creation and refinement of engineering documentation
- Provide training for manufacturing team members
- Ensure adherence to good manufacturing practices (GMP) and safety procedures

**What you need**
- Bachelor's degree in Engineering or related field required
- 2+ years of relevant work experience required
- Bilingual fluency (English & Spanish)
- OnePLM and Valgenesis experience highly preferred
- Good knowledge of manufacturing processes, materials, product and process design preferred
- Experience with engineering development, including installation qualification, operational qualification, performance qualification (IQ/OQ/PQ), or equivalent experience
- Leading and coordinating team efforts through projects - preferred
- Experience in a FDA regulated or medical device and/or biotech field - preferred

**About Stryker**:
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

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