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Overview

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let’s improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

The Reliability Engineer will join the Selution DCB operations team, they will predominantly be responsible for driving the organization through 6-sigma initiatives and KPI driven decisions. This will require evolving the existing data bases to generate site wide visual management communications and holding the organization accountable to both recognizing and actioning trends. In addition, this position will heavily leverage 6-sigma experiences as the site embarks on a significant capacity expansion tracking to the launch in the US market, requirements from the position will range from supporting/leading initiatives in manufacturing, supply chain, supplier and audit related activities. This position offers a unique opportunity to someone with a background in data analysis/trending as a core competency and who can apply those skills to an organization rapidly expanding which required guidance through performance data.

Responsibilities

Key Accountabilities

• KPI development & management: Leverage and evolve existing data bases to produce actionable trends, identify and drive installation of data management improvement systems, together with the operations cross functional teams, identify and enable refined OR new KPIs necessary to drive the business.

• Capacity Expansion team member: as the site undergoes significant transformation, work with the operations team to evolve both the QMS and the manufacturing environment in order to scale to US market, and growing global demands.

• Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.

• Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.

• Regulatory Compliance: Stay up-to-date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.

• Supplier Collaboration: Working with the supplier quality engineers and quality control dept assess opportunity for improvement in the quality of incoming components and materials.

• Root Cause Analysis: Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions.

• Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP)..

• Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.

• Mentorship & training: provide technical guidance to operations personnel (engineering, quality, R&D and manufacturing), fostering their professional growth and development within the organization.

Strategic Impact

• Establish a data driven culture & propose strategy for management decisions

• Quality support to develop next gen process and ramp up to meet market requirements

• Quality lead on support and implementation of revised QS

Key Interactions

• Reports to a senior leadership position.

• Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.

• At least 3 years in medical device production development

• Six Sigma black or green belt, CRE, CQE or CQT [preferred]

• Previous experience with product lifecycle (post market) commercial support [preferred]

• Previous experience working in a clean room environment [preferred]

Competencies & Skills

• Strong engineering and quality background

• Team Leader, ability to inspire and support a team.

• Proven track record in global regulatory body interactions

• Strong communication skills.

• Global, International Orientation

• Ability to make independent decisions

• Fluent in English

Physical Requirements

• Light office work and telecommute capability.

• Available to travel 20% of the time, as required domestic and international

• Must be able to lift and carry up to 15 lbs.

Pay / Compensation

The expected pre-tax pay rate for this position is $73,700 - $100,000

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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Job Locations US-CA-Irvine

ID 2025-3334

Category Quality/Regulatory

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com