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Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

The **Principal Manufacturing Quality Engineer** will be responsible for ensuring that our medical devices meet the highest quality standards throughout the operations and manufacturing process, as well as responsible for overseeing and managing operations quality programs, initiatives and guiding the operations team through production scale up, end-to-end product realization and associated quality deliverables. The primary focus will be supporting our organization in bringing new therapy to the market through developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position will collaborate with cross-functional teams, drive process improvements, and champion a culture of quality excellence.

Responsibilities

Key Accountabilities

+ Operations lead which includes manufacturing oversight and manufacturing dependent upstream and downstream processes.

+ Manufacturing primary point of contact for the engineering team supporting direct manufacturing

+ Quality Control oversight: Supporting the engineers to monitor and implement quality control measures at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements.

+ Process Improvement: Lead the engineers through continuously identifying and implementing 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.

+ MDR: Primary point of contact for the quality operations team for MDR, with potential for this position to assume the quality program manager on MDR.

+ Supplier Collaboration: Work closely with supplier engineering group to assess and improve the quality of incoming components and materials, fostering strong supplier relationships.

+ Root Cause Analysis: Lead the team through investigation and resolution of 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).

+ Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices.

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

+ Product Testing: Oversee and coordinate product testing, validation, and verification processes to ensure products meet required specifications.

+ Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.

+ Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.

Strategic Impact

+ Operations team member enabling manufacturing operations and the manufacturing key dependent processes.

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

+ Quality lead on support and implementation of revised QS

+ MDR quality lead

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.

\#LI-VC1

Qualifications

Education and Work Experience

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

+ At least 8 years in medical device production development

+ Previous experience with product lifecycle (post market) commercial support

+ Previous experience leading programs supporting business and regulatory strategy

+ 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

Pay / Compensation

The expected pre-tax pay rate for this position is $93,816 - $160,000 per year

Full time position

Actual pay may fluctuate outside of the 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.

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**Job Locations** _US-CA-Irvine_

**ID** _2024-3203_

**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 [email protected]