Senior Principal Systems Engineer (Remote/Flexible)

Position Overview: 
We are looking for a self-motivated Senior Principal Systems Engineer to join the Life Cycle Engineering team responsible for sustaining and implementing breakthrough improvements to on-market products. In this position you will be responsible for leading system verification activities comprising test method design, development, execution, and reliability engineering efforts across multiple product lines. You will also be deeply involved in root cause analysis efforts and design related activities intended to improve customer experience. Education and work experience should encompass a vast array of engineering disciplines to include, software, communications, electrical, mechanical, and materials. 
 
Responsibilities: 
• Serves as organization spokesperson on specialized projects or programs. Acts as prime consultant on large projects that effect the organizations long-term goals and objectives and may be responsible for approving or signing off managerial-level output documents.  

• Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables 
• Lead and mentor other systems engineers supporting Life Cycle Engineering 
• Ensure products are defined by and comply with all applicable requirements such as customer, regulatory, environmental and use case needs related to specified applications and market needs 
• Catalog, promote and standardize the use of existing test methods 
• Lead design, development, execution of novel test methods and risk management activities utilizing best engineering practices 
• Conceptualize tests needs and translate them into test fixture requirements and test specifications 
• Lead contractors and work with in-house engineers to design the necessary test fixtures and verification methods in order to ensure product quality standards are met 
• Lead integration, subsystem and system verification activities creating plans, protocols and reports as necessary. 
• Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. 
• Promote the use and mentor individuals across different departments on best systems engineering practices. 
• Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders. 
 
Education and Experience:  
• A Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is preferred, a Master of Science degree is a plus; System Engineering training and/or certification is a plus. 
• A minimum of 12 years’ experience working as a Systems Engineer or with systems engineering Responsibilities: in a multidisciplinary project team environment. 
• 2+ years of experience in leading a cross-functional development team. 
• Domain expertise in at least two associated domains; Mechanical, Electrical, Software and Test Engineering 
• Experience writing verification plans, protocols and reports according to medical device regulations. 
• Experience with Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA). 
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). 
• Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts. 
 
Preferred Skills and Qualifications 
• Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is a plus. 
• Experience with advanced root cause analysis methods such as Statistical Analysis, Cause and Effect, A3, 5 Whys and 8Ds. 
• Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS. 
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices (3) in the drug delivery market. 
• Experience using Minitab, ReliaSoft or similar tools. 

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Travel is estimated at 25% but will flex depending on business needs

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.