Post-market Surveillance Engineer I
hace 7 meses
At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. To accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication, and Collaboration. Come and join Team MicroPort
**Why You’ll Love MicroPort**
You will find our team atmosphere is warm, challenging, and rewarding. In addition to working with a world-class team locally and abroad and receiving a competitive salary, our Costa Rican employees also enjoy the following benefits: Medical Insurance, which includes Dental and Vision, Leaves of Absence, including Bereavement, Maternity and Paternity Leave, Studies, paid and non-paid additional days; Seniority Days, Paid Holidays (10 each year), Education Assistance...and more At MicroPort, we care about our employees.
**Your duties will include**:
- Organize and conduct PMS meetings according to the established meeting schedule.
- Provide key product safety analysis by preparing complaint rates and complaint trends reports.
- Conduct search and review published information and provide summary reports on published clinical data for the MPO and competitive products. Assist in writing initial Clinical Evaluation reports (CERs).
- Review Device Registries and government databases for MPO and competitive products.
- Write and distribute summary PMS reports and update the electronic database.
- Routinely update CERs with new PMS data after each PMS review.
- Provide training on the Post Market Review procedure and database-keeping.
- Work closely with the respective departments to identify and analyze trends arising from product complaints, clinical studies, competitive products, literature reviews, etc.
- Provide input into identifying failure modes and risk assessment for new products under development review FMEA reports.
- Analyze, interpret, and disseminate results from clinical studies.
- Create and update Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs).
**Other Duties** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.
**About You**
**We might be a great match if you**:
- Are familiar with basic orthopedic knowledge (i.e., anatomy, diseases of joints, science of joint replacement, etc.) to read and comprehend published scientific literature.
- Possess strong leadership skills and excellent analytical and problem-solving abilities.
- Have good English level, as well as good communication skills and technical writing skills.
- Having some experience in the medical device industry with a focus on clinical research, quality, reliability, or development engineering is preferred.
- Are an entry-level with a strong engineering background and independent research skills.
- Must work well within a team environment.
- Must have the ability to balance multiple ongoing projects, timelines, and outputs.
**YOUR EDUCATION**
Bachelor’s Degree in a Science/Engineering/Technical or related degree.
**YOUR EXPERIENCE**
Minimum 1 year required, including a combination of internship and/or research experience.
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