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Overview

MedAlliance, 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. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

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.

We are seeking a proactive and detail-oriented Sr Product Performance Engineer to support the manufacturing of high-quality medical devices. This role involves investigating product performance issues, driving compliance with regulatory standards, and analyzing and optimizing manufacturing processes. A key focus will be on addressing customer complaints, non-conformance reports (NCMRs), Corrective and Preventative Action reports (CAPAs) and other quality concerns to ensure the reliability and safety of our products.

Responsibilities

• Investigate product complaints using root cause analysis tools, evaluate potential manufacturing or design issues, leverage Risk Management Files, and consult with clinically trained associates for events within a designated product category

• Responsible for mentoring other engineering staff in the use of quality tools and root cause investigations.

• Communicate aggregated data obtained from product evaluations to New Product Development, Product Risk Management, and Commercial Product Teams

• Maintain detailed and accurate records of complaint investigations, NCMRs, testing methodologies, results, and improvement initiatives. Prepare technical reports for internal stakeholders and regulatory bodies.

• Analyze and resolve Non-Conformance Material Reports (NCMRs), ensuring timely disposition of non-conforming products. Work closely with Quality Assurance and Manufacturing teams to implement improvements and prevent recurrence.

• Report post market surveillance data Key Performance Indicators for Management Review within a designated product category

• Evaluate and optimize manufacturing processes to enhance product performance and consistency. Identify and address process bottlenecks or inefficiencies, implementing solutions aligned with Lean and Six Sigma principles.

• Develop and execute performance testing protocols for manufacturing processes and finished products, ensuring compliance with regulatory standards (e.g., FDA QSR, ISO 13485).

• Responsible for writing and execution of in-house process and/or method validations and the SOPs developed. This includes assisting in the design and development of processes and/or measurement system methods and tooling for the test and inspection of the manufacturing process and products.

• Collect and analyze performance and quality data from manufacturing processes, customer feedback, and field performance. Use statistical tools to interpret trends and recommend process or product improvements.

• Responsible for working with suppliers, where necessary, in support of failure investigation activities.

• Collaborate with cross-functional teams to drive process improvements and implement design-for-manufacturability (DFM) enhancements. Facilitate the implementation of corrective actions identified during investigations or audits.

• Responsible for assisting in internal and external audits where requested.

• Responsible for establishing and reporting quality goals and metrics to all levels of the company as well as implementing action plans in a timely manner to meet requirements.

• Responsible for assisting and mentoring other associates in technical investigations, data handling techniques/analysis, and report writing.

• Stay informed of regulatory trends and other external expectations regarding product investigations

What You’ll Need To Succeed

• Hands on skills for device malfunction investigation, documentation, and technical writing

• Understanding of Catheter/Balloon/Drug Coating manufacturing processes

• Excellent task prioritization and time management skills.

• Work independently and proactively to manage responsibilities.

• Translate investigation learnings into materials for technical teaching/training sessions.

• Excellent soft skills with the ability to quickly adapt to change.

• Proficient at technical writing and report creation skills.

• Experience with Lean manufacturing and Six Sigma methodologies.

• Familiarity with ERP systems and production monitoring tools.

• Knowledge of cleanroom manufacturing and sterilization processes for medical devices.

• Experience working with quality systems compliant with FDA QSR and ISO 13485.

Qualifications

• Bachelor’s Degree in Engineering or related and minimum 5 years’ experience conducting product complaint investigations, in a regulated industry, using risk management tools

• Proven experience in a manufacturing or quality role in the medical device industry.

• Strong knowledge of complaint investigation processes, CAPA systems, and NCMR workflows.

• Familiarity with manufacturing process validation (e.g., IQ, OQ, PQ) and device testing standards (e.g., IEC 60601, ISO 14971).

• Proficiency in statistical analysis tools (e.g., Minitab, JMP) and experience with root cause analysis techniques.

• Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams.

• Ability to multi-task and manage competing project and business priorities

• Ability to travel up to 5%

Desired Qualifications:

• Medical Device, Healthcare or Pharmaceutical experience strongly desired

• Previous responsibilities in Manufacturing Engineering, Design/Quality Assurance

Pay / Compensation

The expected pre-tax pay rate for this position is $91,850 - $122,650

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

Benefits: Med Alliance offers a competitive benefits package including:

• 401(k)

• Medical, Dental and Vision Insurance

• Life insurance

• Paid time off

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Job Locations US-CA-Irvine

ID 2024-3227

Category Manufacturing

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