Product Manager Medical Device

Product Manager - Medical Devices

Context

We're looking for a Product Manager for our Hardware Devices Team. This team produces both communications equipment that interfaces with medical equipment and produces medical equipment, like ECG machines, as well.

These are electronics hardware devices that are coupled with firmware internally, software externally and algorithms.

The successful HDPM will need to have a broad based understanding of three disparate areas:

- The first and most important is the ability to develop a good idea of customer needs from the business teams.

The HDPM must be careful in parsing through a lot of secondary data from them and willing to collect data from primary sources in the field as well. The successful HDPM will need to have an opinion about customer requirements based on all these data points. This is the what and why of the product.

- Second, the HDPM should have a detailed understanding of the functionality and limitations of the technology used to build the product. Since the HD Team is building electronics, an in depth understanding of electronics and experience building them is going to be a big plus. However, we do have fantastic technical leads so as long as you have the attitude and aptitude to learn, you'll be fine. You will be required to work with the hardware, software and algo leads to work on an architecture that should include the pros and cons of each consideration of how the market needs can be fulfilled. Again, here too, you must be opinionated on some technology choices based on what will and may not work in the market based on needs and pricing. This is the how of the product.

- Third, the HDPM will be key in understanding the standardization and certification requirements for the product for each country that we would want to market it in over a horizon of a few years. The candidate must be able to read through multiple standards and work with the regulatory team to understand the boundaries of testing for safety and efficacy of the product. The HDPM must have enough knowledge of the standards that they can explain the needs to the leads to inform technology decisions and constraints to the business teams. Through the above, the candidate must be able to build and maintain the design, development, testing and certification plan going toward product launch and post market surveillance.

Responsibilities

- Create and maintain Product requirements

- By speaking with the stakeholders like business owners, sales teams, and support team regularly

- On the direction of the product owner (Hardware Devices Team Head)

- By analyzing usage, complaints and market indicators.

- Delivery of features

- By planning the feature development

- By working closely with the engineering team to align them with the requirements

- By tracking the development progress

- Good quality of the product

- By developing the verification and validation plans

- By working with the quality team to execute on the verification and validation suite

- Adherence to 13485 and 62304 standards.

- By understanding the requirements of these processes through reading and training.

- By ensuring all the correct development processes are being followed

- By creating the documentation required

- Maintaining Product roadmap

- By speaking with the stakeholders like business owners, sales teams, and support team regularly.

- By gathering market information, industry trends

- By evaluating new product ideas

- By analyzing competitors by understanding their products

Skills

- Ability to write product requirements and other formal documents with precision and clarity.

- Background in technology. A hardware development background will be a plus.

- Project management skills to create and maintain project plans in Gantt tools.

- Personal time management skills to ensure that no tasks are lost and no threads are lost without follow up.

- Appreciation of processes and doing activities as per the process.