Post-Market Surveillance Engineer II or Sr.

MicroPort Orthopedics

Posted on: May 12, 2022

Closing: June 11, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

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!

*Hybrid Working Schedule Available*

 Overall Summary

As Post-Market Surveillance Engineer II or Sr., your main  function will  be gathering, analyzing, and disseminating information on clinical safety and performance of MPO products and its competitors to fulfill global regulatory requirements and support strategic business initiatives.

 

Job Responsibilities

  1. You will be responsible for 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, summary of collected feedback from all sources, such as media, sales force, and competitors’ websites.
  2. You will be be responsible for scheduling and facilitating PMS review team meetings and writing and distributing meeting minutes. You will be responsible for following up on the action assignments generated from these meetings to ensure their timely completion.
  3. You will assist Regulatory Affairs group with new product submissions and license renewals by providing results from PMS review findings and answering questions from various government agencies.
  4. You will provide 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, you may assist with conducting literature searches and MAUDE database searches for the initial Clinical Evaluation Report.

PRINCIPAL ACTIVITIES:

  1. Organize and conduct PMS meetings according to the established meeting schedule.
  2. Provide key analysis of product safety by preparing complaint rates’ and complaint trends’ reports.
  3. 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).
  4. Review Device Registries and government databases for MPO and competitive products.
  5. Write and distribute summary PMS reports and update the electronic database.
  6. Routinely update CERs with new PMS data after each PMS review.
  7. Provide training on the Post Market Review procedure and database keeping to new employees.
  8. Work closely with the respective departments to identify and analyze trends arising from product complaints, clinical studies, competitive products, literature reviews, etc.
  9. Provide input into identifying failure modes and risk assessment for new products under development, review FMEA reports.
  10. Analyze, interpret, and disseminate results from clinical studies.
  11. 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.

Required Skills, Knowledge and Abilities

  • Must be familiar with basic orthopedic knowledge (i.e. anatomy, diseases of joints, 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.
  • Some experience in the medical device industry with the focus on clinical research, quality, reliability or development engineering is preferred.
  • Entry level with strong engineering background and independent research skills will also be considered.
  • Must work well within team environment.
  • Must have the ability to balance multiple ongoing projects, timelines, and outputs.

Accountability

You must adhere to strict timelines established by other departments for regulatory submissions, government inquiries, etc. Outside of this requirement, freedom to assist with other projects exists. It must be pointed out that this position is a support function and as such has deadlines and deliverables established for them by other groups. Financial impact is reflected in sales dollars for products with delayed introduction or products that are placed on regulatory hold due to the lack of clinical data.

Key activities that may affect sales revenues:

  • Ensure timely conduct of the Post-Market Surveillance meetings
  • Provide required support to Product Development, Marketing, Regulatory Affairs, Quality Affairs, and Clinical Affairs teams

EDUCATION REQUIREMENTS

Required: Bachelor’s Degree in a Science/Engineering/Technical or related degree

Preferred: Master's Degree

Education should include courses in design, material science, statistical analysis and technical writing.

EXPERIENCE REQUIREMENTS

II: Minimum 3 years related experience required, including a combination of internship and/or research experience

Sr. Minimum 5 years related experience required, including a combination of internship and/or research experience

MicroPort Orthopedics

Posted on: May 12, 2022

Closing: June 11, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Engineer

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