We recently interviewed one of our contractors, Sanjoy C, to find out what it’s like to work as a R&D Product Development Engineer. We asked what a general day involves, what experience and qualification are required for this job and what advice would he give to aspiring R&D Product Development Engineers.

Q1. What is your job title?

R&D Product Development Engineer (New Product Development, Orthopaedic Trauma)

Q2. What does the company you work at do?

The company I work at is a leader in orthopaedic trauma devices for internal and external fixation.

Q3. What is your background?

I have a Bachelor of Engineering (Mechanical) and I have 12 years of R&D experience in NPD and product maintenance/sustenance in the orthopaedic domain. I also have 10 years of NPD experience with global R&D teams, with specific responsibilities of designing and developing state-of-the-art orthopaedic trauma, spine and joint reconstruction implants and instruments; creation and maintenance of design history file (DHF) and risk management documentation.

Q4. What does your job involve?

My job involves leading the creation of Design Risk Management documents of implants and instruments of multiple ongoing new Trauma Nailing system projects. This includes collaboration with Quality, Marketing, Medical Affairs and Regulatory. I support the creation of additional design control documents, including Tolerance Analyses and Design Verification documents.

Q5. What is a typical day like in your role?

Design Risk Management is a pretty intensive, specialised activity which starts with analysing the design of orthopaedic instruments and implants to identify all possible modes of failure of the device. It is important to keep in mind the possible ways the devices may be used by the surgeon during surgery. When it is a new product, an engineering estimation needs to be calculated by first identifying suitable reference products which are out in the market. The product complaints of those reference products need to be analysed to explore all possible ways the reference products may have failed in the field.

Thereafter, based on the performance of the reference products, a logical estimation needs to be made regarding how often and in which possible ways the new device may fail during surgery. Often there may not be a reference product which has a close resemblance with the new product. In such scenarios, all possible on-market devices need to be explored to identify suitable references. Apart from identifying the ways in which a device may fail, the creation of design risk management also involves defining the strategy in which the failures may be prevented. This often involves interactive discussion with the engineer who is responsible for the design and development of the concerned device. When the document is ready, it is the job of Product Development Engineer to interact with Design Quality and get the document reviewed and updated. Apart from Design Quality, the PD Engineer needs to interact with Medical Affairs to finalize the clinical harms that can happen to patients as a result of possible failures of the device. The PD Engineer also needs to interact with Regulatory Expert and Marketing Specialist for additional reviews and marketing. Overall, the daily activity of a PD Engineer, working on Design Risk Management, involves the shoes of a cynical engineer, a hardcore crime detective and a creative English author, who is also good in managing the aspirations and raised eyebrows of multiple reviewers and senior management.

Q6. How did you get into your current job role? (Did you need a certain qualification or experience?)

You can work effectively on the creation of Design Risk Management if you yourself have strong experience in product design, knowing how orthopaedic products typically fail. Apart from this, you need to be strong in logical thinking and smart writing. At the end of the day, the Design Risk Management document should not only ensure that the design of the products are robust and they do not fail easily, but the document should also ensure that all necessary regulatory need has been taken care of. When FDA auditors audit a new product system, they often start with the Design Risk management document. So, it is very much necessary, that apart from having sound, relevant experience, one has a logical mind and a logical sense of writing.

Q7. What do you enjoy most about your job?

Creating the design risk management of an entire orthopaedic system increases my overall knowledge of the entire system and the strengths and weaknesses of each and every device of the system. It also exposes me to the entire clinical use of the system – all possible ways the surgeons are going to use the system. In recent years the regulatory bodies in USA & Europe have emphasized a lot on the design risk management of medical devices. The top management of medical device companies provide utmost importance to the creation of design risk management document. The challenge of this work and the appreciation that it enjoys from senior management provides me with a lot of satisfaction.

Q8. What is the hardest part of your job?

The hardest part is that it is pretty intensive, often involving reviewing 500 plus complaints about a reference device, if the reference device had a problematic history in the market. That requires patience but, it’s easy to overcome the monotony if you realize that your work is going to ensure that the new device doesn’t fail as often as the problematic reference device.

Q9. Why did you decide to pursue this career?

It is the job of a complete PD Engineer to know how to design and develop a product from scratch to final release in the market, including authoring of all necessary Design Control documents. In an ideal situation, a single PD Engineer should be not only designing the product, but also create the Design Risk Management document. As a PD Engineer, currently, I am working on Design Risk Management, but, I have worked in most areas which are in the jurisdiction of a PD Engineer.

Q10. What can this type of job lead on to?

A PD Engineer would ultimately grow up to be Technical Manager or move to an Operations Managerial role. Often PD Engineer moves to marketing and works directly with surgeons to define upfront the need of the market. A PD Engineer can also migrate to the role of a Design Quality Engineer.

Q11. What advice would you give to somebody considering this role as a career?

If you have a passion for designing and developing orthopaedic products, you are definitely going to enjoy this career.

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