The Medical Device industry is clamoring for Software Engineers & IEC standard knowledge is a must.

Posted by:whitridge
26 October 2020 0

Despite uncertainty in the overall job market, the Massachusetts medical device industry is booming.

MassMEDIC’s second annual Massachusetts medical device industry report (2019) reported, “Massachusetts leads all other states in medical products exports as a percentage of total exports with a value of $5.7 billion,” and “The over 400 medical device companies in Massachusetts contribute 23% of the state’s total exports, again the highest in the nation.”

Their findings also showed a strong job market in med device as well, “Massachusetts ranks third for total number of medical device employees with 24,815 workers in that field. Cambridge is the 13th metropolitan area nationwide with the largest proportion of workers in science or engineering occupations (8.8%).”

Whitridge’s Quality, Validation, and Regulatory recruiting practice provides specialized staffing services to some of Massachusetts’ and the Nation’s top medical device companies and has seen a strong need for software developers, engineers, software quality engineers, and software test engineers, due in large part to companies working tirelessly to bring Digital Robotic Surgery to the OR. Many software groups have risen in the ranks to have the some of the biggest head counts in the industry.

While a strong Software Engineer will be able to analyze the users’ needs and then design, test, and develop software to those needs and recommend upgrades for existing systems among other responsibilities, understanding specific standards can make a software engineer stand out from the crowd. Many clients place an emphasis on a candidate’s ability to not only understand but master ISO and IEC standards, including IEC 62304 and IEC 60601.

ISO, the International Organization for Standardization, publishes international standards for everything from quality management to IT security standards. ISO defines IEC 62304 and IEC 60601 as follows:

IEC 62304:2006

This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

IEC 60601

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel.

It benefits medical device companies to have Software Engineers that have a clear vision for how their plans comply with IEC standards.

Although the ISO does not offer certification in-house, they do work with organizations like the IAF and ILAC that offer accredited testing and certifications, you can find direction on where to get certified, here.

Whether you’ve been in the industry for a short time or have decades of experience – getting certified in an area of expertise can show employers that you possess the skills to move their project forward.

If you’re a manager in the medical device space, looking for quality candidates to join your team – Whitridge can help. And if you’re a candidate, looking for your next job opportunity – the Whitridge recruiting team is here to find your next role in the medical device field.

This blog post was written by Danielle Larson, Talent Acquisition & Engagement Specialist

About Whitridge Associates

Whitridge Associates provides expert talent to a diverse group of technology companies, financial services, defense contractors and healthcare providers throughout the country. With a history of 25 plus years of unparalleled service to both our clients and consultants, Whitridge’s IT Recruiters Boston are the most highly regarded business and technology staffing companies in New England. Whitridge was recently recognized as an Inavero’s Best of Staffing® Client and Talent Awards winner for the fifth year in a row, one of the top 100 fastest growing staffing companies in the United States and was presented with The Excellence Award from TechServe Alliance the industry’s leading trade association.

Whitridge helps our clients and candidates achieve business success.  Think Whitridge. Think Success. www.whitridge.com

SOURCE MATERIAL

https://www.iso.org/obp/ui/#iso:std:iec:62304:ed-1:v1:en

https://www.iso.org/standard/65529.html

https://www.massmedic.com/wp-content/uploads/2019/07/grantthorntonmedicaldevicesinMassachusettsStateoftheIndustryjuly2019.pdf

https://www.iso.org/certification.html