Post-Market Surveillance Engineer I

hace 2 semanas


San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo

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, and 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**

Minimum 1 year of related experience, 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 will ideally include design, material science, statistical analysis, and technical writing courses.



  • San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo

    About the RoleAs an Orthopedic Post-Market Review Engineer at Microport Orthopedics, you will be responsible for ensuring the highest level of quality and safety in our medical devices. This is a key role that requires strong analytical and problem-solving skills, as well as excellent communication and technical writing abilities.Key...


  • San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo

    Job DescriptionThe Medical Device Surveillance Specialist will play a crucial role in ensuring the compliance and safety of Microport Orthopedics' medical devices. The ideal candidate will have a strong background in engineering, regulatory affairs, or a related field.Responsibilities:Conducting post-market surveillance activities in accordance with company...

  • E&I Senior Engineer

    hace 4 semanas


    San José, San José, Costa Rica Emerson A tiempo completo

    **Description:**As part of the Electrical and Instrumentation Group, the E&I Intermediate Engineer I is responsible for overseeing and performing electrical and instrumentation engineering and related activities associated with PSS projects, based on customer specifications and in line with project strategy and Project Management Office (PMO)...

  • Senior Data Analyst

    hace 2 semanas


    San José, San José, Costa Rica Smith+Nephew A tiempo completo

    Life Unlimited.At Smith+Nephew we design and manufacture technology that takes the limits off living.Are you looking for a new opportunity where you can develop yourself?The Data Analyst - Complaints is developing, analyzing, and disseminating the global complaint data used for workload management, audits/inspections, performance metrics, global periodic...


  • San José, San José, Costa Rica International Talent Resources A tiempo completo

    Job Summary: We are seeking an experienced Site Reliability Engineer to join our team. This is a 12-month contract opportunity with a competitive salary range of $10,000 - $20,000 per month.


  • San José, San José, Costa Rica Emerson A tiempo completo

    Company OverviewWe are Emerson, a leading provider of innovative solutions for the industrial automation market. Our Inside Sales Engineer I role is an exciting opportunity to join our team and contribute to our mission of delivering exceptional value to our customers.

  • Market Research Analyst

    hace 2 semanas


    San José, San José, Costa Rica Skim A tiempo completo

    Company DescriptionWho is SKIM?SKIM is a fast-growing marketing research consultancy with offices in the US, Europe, Asia and South America.For over 40 years, we have been trusted partners to the world's largest CPG, technology and healthcare brands.We specialize in modelling and understanding people's decision making in the areas of Brand Communications,...

  • Software Engineer I

    hace 4 semanas


    San José, San José, Costa Rica Imprivata A tiempo completo

    Come join a winning teamHere at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare.Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events.While we're diverse in our backgrounds and skills, we have much in common.A passion for our...

  • Software Engineer I

    hace 4 días


    San José, San José, Costa Rica Imprivata A tiempo completo

    Come join a winning teamHere at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare.Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events.While we're diverse in our backgrounds and skills, we have much in common.A passion for our...

  • Automation Engineer I

    hace 3 semanas


    San José, San José, Costa Rica Imprivata A tiempo completo

    Come join a winning teamHere at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare.Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events.While we're diverse in our backgrounds and skills, we have much in common.A passion for our...

  • Senior Sales Engineer

    hace 7 días


    San José, San José, Costa Rica Emerson A tiempo completo

    About the RoleAs a Inside Sales Engineer I at Emerson, you will play a critical role in providing technical support to customers and ensuring their needs are met. This is an exciting opportunity to join our team and contribute to our mission of delivering innovative solutions.

  • Software Engineer I

    hace 4 semanas


    San José, San José, Costa Rica Imprivata A tiempo completo

    Come join a winning teamHere at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare.Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events.While we're diverse in our backgrounds and skills, we have much in common.A passion for our...

  • Software Engineer I

    hace 2 semanas


    San José, San José, Costa Rica Imprivata A tiempo completo

    Come join a winning teamHere at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare.Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events.While we're diverse in our backgrounds and skills, we have much in common.A passion for our...


  • San José, San José, Costa Rica Bairesdev A tiempo completo

    BairesDev se enorgullece de ser la empresa de software outsourcing de más rápido crecimiento de América.Nuestros equipos están conformados por personas de todo el mundo, lo que nos permite contar con una fuerte esencia multicultural.Para ofrecer constantemente soluciones de la más alta calidad, contratamos solo al 1% superior de los mejores talentos y...


  • San José, San José, Costa Rica Johnson Controls A tiempo completo

    Job DescriptionGoal Support the Sales & Engineering teams on pre-sales and post-sales multi-faceted projects with technical activities such as takeoff, drawings, bill of materials and design.Essentials Functions Support on Request for Proposals working on takeoffs, bill of material creation, pricing, etc.Create pre-design drawings (Spots & Dots), shop...


  • San José, San José, Costa Rica Bairesdev A tiempo completo

    BairesDev se enorgullece de ser la empresa de software outsourcing de más rápido crecimiento de América.Nuestros equipos están conformados por personas de todo el mundo, lo que nos permite contar con una fuerte esencia multicultural.Para ofrecer constantemente soluciones de la más alta calidad, contratamos solo al 1% superior de los mejores talentos y...


  • San José, San José, Costa Rica Canonical - Jobs A tiempo completo

    This role is an opportunity for an EU resident technologist with a passion for Linux and Cloud to build a career with Canonical and drive the success with those leveraging Ubuntu and open source products.If you have an affinity for open source development and a passion for technology, then you will enjoy working with some of the best people in the industry...

  • Software Engineer L

    hace 4 semanas


    San José, San José, Costa Rica Grupo Syntepro A tiempo completo

    What do I need to succeed?2+ years professional experience as a software engineer Full stack capable with proficiency in at least one language (JavaScript, Python, or similar) You have deployed software to a cloud platform Experience with a distributed system Fintech experience will help, but not required.We are complex, which is funWhat we look like...

  • Automation Engineer

    hace 2 semanas


    San José, San José, Costa Rica Northwind Technical Services A tiempo completo

    Job Purpose:The Automation Engineer I is responsible for ensuring the safety, financial, and technical success ofprojects and work assignments related to the support, service, maintenance, and upgrading ofNorthWind's product offerings.Job Duties and Responsibilities:- Attend NorthWind in-house training- Design and review electrical drawings- Perform customer...


  • San José, San José, Costa Rica Kavin Group A tiempo completo

    We are seeking a highly skilled Mechanical Operations Engineer to join our team at the waste processing plant. In this role, you will be responsible for performing maintenance and repair tasks on a range of equipment, including pumps, valves, and hydraulic systems.ResponsibilitiesPerform routine maintenance tasks, including inspections and...