Medical Device & Regulations Engineer

Job Title: Medical Device & Regulations Engineer
Location: Irvine, CA (Onsite)
Duration: Contract
Job Description
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are:
• Develop and implement qualification plans: Design comprehensive test protocols and procedures to evaluate components against specified requirements and industry standards.
• Document and report findings: Accurately record test results, analyze data, and generate detailed reports summarizing findings and conclusions for management and stakeholders.
• Collaborate cross-functionally: Work closely with R&D, Manufacturing, and Quality teams to optimize component selection, address issues, and ensure compliance with medical device regulations throughout the product lifecycle.
• Support continuous improvement: Identify opportunities to enhance component qualification processes, methodologies, and test procedures to improve efficiency and effectiveness.
• Supplier evaluation: Assist in the evaluation and qualification of component suppliers, ensuring their manufacturing processes and quality controls meet established standards.
• Troubleshooting and root cause analysis: Investigate component failures or nonconformances, identify root causes, and implement effective corrective and preventive actions.
• Maintain documentation: Ensure all qualification documentation, including protocols, reports, and procedures, is accurate, up-to-date, and compliant with regulatory requirements.
• Experience with statistical techniques like Design of Experiments (DOE) and data analysis tools.
• Knowledge of specific component types or technologies relevant to the BWI product portfolio
• Can supervise, coordinate and technically revise the work of a limited group of technicians
• Know & follow policies & procedures related to work activities performed in area of responsibility
• Complete training in area of responsibility within allowed time-period and periodic retraining in areas
GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs
• Strong creative, analytical and problem-solving skills.
• Proficient at interpreting data and putting that data into a report
• Experience in PLM Tool (Windchill)
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.