Principal Engineer

hace 3 semanas

Monterrey, México BAXTER A tiempo completo

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The Principal Engineer - Product Quality/Design Assurance, is an embedded partner member in R&D project teams in the sustainment of sophisticated medical device projects on time with the highest quality and product safety.

Responsible for participating in various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company’s regulatory compliance profile. Will frequently interact with and influence project team members and project team’s leaders.
The Principal Engineer - Product Quality/Design Assurance role is responsible for supporting the R&D project team through the sustaining engineering processes at the Monterrey, Mexico site.

**What you will be doing**:

- Responsible for all Design Assurance functions as a core team member on sustaining engineering teams, ensuring the team complies with all portions of Design Control and related Quality System elements
- Prepare, manage, and/or update all Design Assurance required sustaining engineering deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
- Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures
- Assist in identification and mitigation of product or process-related risks
- Support the CAPA and FA process by performing investigations, root cause analyses and verification of effectiveness checks for design related issues impacting the field. Support internal and external regulatory and customer audits.
- Support adherence to process in Concession Reviews, Engineering Change Reviews, and CAPA Review Meetings.

**What you will bring**:

- B.S. in Engineering, preferably Mechanical, Electrical, Electronics, or Computer Engineering.
- 5+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role desired.
- Product Design experience may be considered in lieu of Quality Assurance experience.
- Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards
- Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
- Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure desirable.
- Ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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