As Group Leader of the Medical Device Testing Quality Assurance Team/Unit, Susan oversees the quality and regulatory program for medical devices and combination products tested at the Lancaster site.
Ms. Shorter has extensive experience in the quality field, specifically with pharmaceutical, medical device, instrument and software validation, vendor approval, and internal and external auditing. She has spent several years working in the contract laboratory compliance vector of the industry.
Ms. Shorter holds undergraduate degrees in both chemistry and mathematics from Cedar Crest College and an M.S. in Regulatory Affairs and Quality Assurance from Temple University, Lewis Katz School of Pharmacy.
What first drew you to medtech? When did you first know you wanted to be in the industry?
I have had a love for science since I was young. I have always wanted to know how things worked and why. It also helped that I had a mother who was a biologist and wanted to work in medicine. She never s aid “girls don’t do science” and encouraged me to explor e many scientific fields. By the time I was in 7th grade, I knew a STEM car eer was for me. I took all of the advanced courses I could in chemistry and phy sics while in high school. I started college thinking I was going to be a chemical engineer but ended up with a dual major in chemistry and mathem atics. Throughout my career, I knew I wanted to stay in quality, and when the opportunity came up to help develop a quality pr ogram for a new medical device business unit at Eurofins, I jumped. Working in medical devices inspired me to get my master’s degree.
What are some of the barriers women face in today’s MedTech industry?
Themselves. We bring our unconscious biases with us about women working in a career that is traditionally dominated by men. I believe women get too insecure about failing, feeling it is not culturally acceptable to be working in a man’s world, or feeling as though they have something to prove. I suggest that those interested in learning about Medtech, go for it. Seek out a mentor that can help you stay on the path of your Medtech career. Acknowledge your biases, and work to move beyond them.
Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome?
My biggest challenge was my own self-doubt that people didn’t take me seriously when first moving into a leadership role. I made sure that I did my research to gain the knowledge that I may or may not have been lacking. I did confidence boosters, practiced my presentation skills, and built relationships with those I was working with. In the end, I am a better leader for all the work I put in at the beginning, and the relationships are still strong with the teams I work with.
What projects, past or present, have made you love what you do?
A project that I enjoyed was one where we were called upon by a client whose imported product was being held at the border and urgently required testing to allow its release. The data was being reported directly through the FDA’s Import Trade Auxiliary Communication System (ITACS) interface. The work had to be done in a rush time frame. As a team, we developed a streamlined process to receive and register the samples into our Laboratory Information Management System (LIMS), document and report the visual inspection, and then report to the FDA in just a few days. It was exciting to be part of that project, knowing that we were playing a key role in ensuring the safety of the imported product and ultimately patient safety.
What projects are you most looking forward to?
The projects I am looking forward to most are those that are not yet realized. I always find it interesting to learn about a client’s innovative and cutting-edge product and how we can meet their testing needs. With technology ever-changing, so do our client’s needs and products. Assembling a team of experts, working through test methods to meet the client’s needs, setting the plan into action, and seeing the success of our planning and execution is very rewarding. Striving for and achieving quality for our clients and their products is my “Why” for working in Medtech.
Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome?
My biggest challenge was my own self-doubt that people didn’t take me seriously when first moving into a leadership role. I made sure that I did my research to gain the knowledge that I may or may not have been lacking. I did confidence boosters, practiced my presentation skills, and built relationships with those I was working with. In the end, I am a better leader for all the work I put in at the beginning, and the relationships are still strong with the teams I work with.
Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career?
I have been fortunate to have great mentors and examples of leadership in my career. While there are many important skills to possess as a leader, for me, the most important skill is to listen. Listening enables me to learn my team’s concerns, and how they want to be developed. When issues arise, we can brainstorm, listen to each other, and develop a path forward.
In your opinion, what more can be done to promote the greater participation of young women in the MedTech industry today?
The most important thing to promote greater participation in the MedTech industry is to break down the stereotypes that women do not work in science. I enjoy science and sharing that joy through scientific presentations and community STEM events.
Earlier this year, I had an opportunity to work with a young lady who was a senior in high school. Her guidance counselor reached out to me to set up a virtual interview. The young lady was very interested in a STEM career. I held several virtual lab tours that allowed me to show her our facility and answer any questions she had. I made sure to show my excitement about working in the Medtech industry to get her excited.
Young women of all ages need more women to reach out to and to have as mentors. They need to know that there are women out there who enjoy science and work in Medtech. The more women promote STEM/Medtech and mentor these young women, the more likely the young women will be to enter the Medtech field.
Why is it important for companies to be more inclusive and have more women in charge?
While the percentage of women’s leadership roles remains below 25% in the MedTech industry, having women in leadership roles and having a diverse team remains important. Companies will benefit from having broader perspectives, which will potentially foster more creative process improvements and business innovations. Multiple studies have shown that having a diverse leadership team fosters better customer understanding, improves overall business performance, improves the company’s reputation, and creates an atmosphere for better problem-solving. The bottom line is, it makes good business sense.