Pm Surveillance Engineer I or Ii
hace 4 semanas
At MicroPort Orthopedics, we are never standing still. We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day. We not only embrace this constant advance in medicine. We celebrate it in our work. We operate with the heart of a start-up but the soul of an industry powerhouse. This is critical to achieving our goal of being the fastest-growing, innovation-driven company in orthopedics. Our top priority isn’t just to help surgeons get patients back on their feet. We want to help patients get back to Full Function, Faster. Come be a part of the journey
**Principal Responsibilities**
- Conducting all necessary Post-Market Surveillance (PMS) activities in accordance with the MPO procedures, European Medical Device Directive/Regulation, and the US FDA requirements. This will include but is not limited to the following: analysis of product complaints and determination of complaint trends; review and analysis of international registries and governmental databases; summary of conducted literature reviews; summary of MPO-sponsored clinical research, a summary of collected feedback from all sources, such as media, salesforce, and competitors’ websites.
- Scheduling and facilitating PMS review team meetings and writing and distributing meeting minutes. A person in this position will be responsible for following up on the action assignments generated from these meetings to ensure their timely completion.
- Assisting the Regulatory Affairs group with new product submissions and license renewals by providing results from PMS review findings and answering questions from various government agencies.
- Providing support to Product Development Engineers in developing DFMEA and Risk Analysis plans for new products under development and will review and approve them. In addition, she/he may assist with conducting literature searches and MAUDE database searches for the initial Clinical Evaluation Report.
PRINCIPAL ACTIVITIES:
- Organize and conduct PMS meetings according to the established meeting schedule.
- Provide key analysis of product safety 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.
- 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 to new employees.
- 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.
**Skills Requirements**
- Must be familiar with basic orthopedic knowledge (i.e. anatomy, diseases of joints, the science of joint replacement, etc.) in order to read and comprehend published scientific literature.
- Must possess strong leadership skills and excellent analytical and problem-solving abilities.
- Good communication skills and technical writing skills are a must.
- Entry-level with a strong engineering background and independent research skills will also be considered.
- Must work well within a team environment.
- Must have the ability to balance multiple ongoing projects, timelines, and outputs.
**Experience Requirements**
- PMS Engineer I:_ Minimum 1 year of related experience required, including a combination of internship and/or research experience. Some experience in the medical device industry with a focus on clinical research, quality, reliability, or development engineering is preferred.
- PMS Engineer II:_ Minimum 3 years of related experience required, including a combination of internship and/or research experience. Some experience in the medical device industry with a focus on clinical research, quality, reliability or development engineering is preferred.
**Education Requirements**
Bachelor’s Degree in a Science/Engineering/Technical or related degree required; Master's Degree preferred. Education should include courses in design, material science, statistical analysis, and technical writing.
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