Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

Join our innovative team as a Quality Engineer, where you will play a pivotal role in ensuring the highest standards of medical device safety and efficacy. Specializing in Production & Process Controls, you will support the company by providing expertise in manufacturing and quality processes, offering guidance, training, and suggestions for improvement. You will propose improvements to our Quality Management System (QMS), and spearhead critical assessments to guarantee that our testing processes are precise, reliable, and compliant with regulatory standards. Your expertise will directly contribute to advancing healthcare solutions, impacting patient lives worldwide.

Key Responsibilities:

Conduct experiments to prove hypotheses Create and validate test methods for design verification and manufacturing inspection testing by utilizing techniques such as measurement system analysis and Gage Repeatability & Reproducibility (Gage R&R) Implement statistical techniques to determine appropriate sample sizes and levels of confidence Implement statistical process controls to monitor validated processes Design engineering test protocols and employ a data-driven approach to collect, analyze, and summarize data into engineering reports Investigate root causes for design and manufacturing issues Document Non-Conformance Investigations (NCIR) Document and implement Corrective and Preventative Actions (CAPA) Develop protocols and reports for Installation, Operational, and Performance Qualification (IQ, OQ, PQ) Collaborate with design and manufacturing teams to assess device risk profile, identify failure modes in manufacturing (pFMEA) Position Requirements

This position requires the following skills and attributes: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related education and experience Effective oral and written communication skills Excellent technical writing skills Work effectively in cross-functional teams Read, analyze and interpret complex documents Working knowledge of Microsoft Office, including Word, Excel, and Outlook Preferred

The following skills and attributes are preferred: Experience in the medical device industry, such as though internships or co-ops Engineering capstone projects related to medical or surgical devices Experience in process verification and validation procedures Experience with project management tools, including Microsoft Project Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab Understanding of manufacturing, quality, and risk management standards Benefits Competitive compensation range: $70000 - $80000 / year (California). Comprehensive benefits package. Training and mentorship opportunities. On-campus wellness activities. Education reimbursement program. 401(k) program with discretionary employer match. Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.