Job Description

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, particularly drug-eluting drug delivery systems, meet the highest quality standards throughout manufacturing and operations. This role will oversee and manage operations quality programs, guide the organization through production scale-up of microsphere and drug-device combination processes, and ensure robust end-to-end product realization and associated quality deliverables.

The primary focus will be supporting the organization in bringing new therapies to market by developing, implementing, and continuously improving quality management systems, ensuring compliance with global regulations, and maintaining high standards for aseptic, polymer-based, and particulate manufacturing processes. This position will collaborate cross-functionally, drive process improvements, and champion a culture of quality excellence.

Key Responsibilities

• Serve as operations quality lead supporting manufacturing, including microsphere production processes such as emulsification, solvent evaporation, particle formation, drying (e.g., lyophilization), and downstream handling.
• Act as the primary manufacturing quality interface for engineering teams supporting direct manufacturing and scale-up activities.
• Provide Quality oversight, ensuring appropriate in-process and release testing for particle size distribution, morphology, drug loading, encapsulation efficiency, and release kinetics.
• Lead process improvement initiatives targeting consistency in microsphere formation, yield optimization, and reduction of variability in critical quality attributes (CQAs).
• Conduct risk assessments (e.g., FMEA) specific to drug-device combination and microsphere manufacturing processes, including risks related to sterility, residual solvents, and polymer degradation.
• Ensure regulatory compliance with applicable standards (FDA, ISO 13485, 21 CFR Part 820, EU MDR), particularly for combination products and controlled drug delivery systems.
• Serve as primary quality point of contact for MDR activities, with potential to assume broader quality program management responsibilities.
• Collaborate with suppliers to ensure quality of raw materials (e.g., polymers, solvents, APIs) critical to microsphere performance.
• Lead root cause investigations for quality issues related to particulate systems, including variability in particle size, drug release profiles, and manufacturing deviations.
• Maintain GMP-compliant documentation for formulation, process validation, and analytical testing.
• Support and lead process validation activities (IQ/OQ/PQ), including validation of microsphere manufacturing processes and associated equipment.
• Provide training on GMP, and specialized microsphere manufacturing processes.
• Support internal/external audits and regulatory inspections with a focus on combination product manufacturing and particulate systems.
• Oversee product testing, validation, and verification, ensuring alignment with defined CQAs and regulatory expectations.
• Mentor junior engineers and provide technical leadership in drug delivery and manufacturing quality systems.
• Contribute to intellectual property strategy, particularly related to drug delivery technologies and manufacturing processes.

Strategic Impact

• Key operations team member enabling robust and scalable microsphere manufacturing processes.
• Drives quality strategy to support next-generation drug delivery technologies and commercial scale-up.
• Leads implementation and continuous improvement of the Quality System (QS).
• Serves as MDR quality lead, supporting global regulatory compliance.

Key Interactions

• Reports to Sr. Manager, Quality Engineering.
• Interfaces cross-functionally with R&D, Manufacturing, Regulatory, Supplier Quality, and external partners.

Required Experience

• Bachelor’s or Master’s degree in Chemical Engineering, Materials Science & Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related field (Chemical Engineering or Materials Science strongly preferred for polymer-based microsphere manufacturing processes)
• 8+ years of experience in medical device and/or combination product manufacturing, with strong preference for experience in:
  • Microsphere or particulate-based drug delivery systems
  • Polymer processing (e.g., PLGA or similar biodegradable systems)
  • Drug product formulation and encapsulation technologies
• Demonstrated experience with:
  • Scale-up of particle/microsphere manufacturing processes (e.g., emulsions, solvent evaporation, drying/lyophilization)
  • Critical quality attributes (CQAs) such as particle size distribution, drug loading, and release kinetics
  • Process validation and technology transfer from development to commercial manufacturing.
• Prior experience supporting product lifecycle management, including post-market activities and continuous improvement.
• Experience leading or contributing to programs aligned with regulatory and business strategy, particularly for combination products.
• Experience working in GMP-regulated cleanroom environments (ISO-classified) preferred.

Competencies & Skills

• Strong background in manufacturing quality engineering and drug-device combination products
• Deep understanding of microsphere manufacturing processes and polymer-based drug delivery systems
• Proven leadership and ability to guide cross-functional teams.
• Experience interacting with global regulatory agencies.
• Strong analytical, problem-solving, and root cause investigation skills
• Excellent communication and stakeholder management abilities
• Global mindset with the ability to operate across regions.
• Ability to make independent, data-driven decisions.
• Fluent in English

Pay / Compensation
The expected pre-tax pay rate for this position is $114,950 – 165,000 per year. 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 teammates’ 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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