Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
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!
· Position Overview:
The Senior Staff Project Leader will be a technical lead for projects within Insulet’s Lifecycle Engineering group. This position entails leading Lifecycle Engineering activities following Insulet’s design change Standard Operating Procedure (SOP-069). Education and work experience should encompass a vast array of engineering disciplines to include, software, electrical, mechanical, and materials besides demonstrated ability to lead complex engineering projects.
Responsibilities:
• Serve as a leader of cross-functional project teams consisting of systems, electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
• Develop and own the Change Development Plan for design changes to Insulet’s on market products.
• Manage a portfolio of projects within the Lifecycle Engineering group.
• Create and maintain project priorities, assist functional management in resource allocation and maintain financial accountability by staying within assigned lifecycle engineering budget.
• Create project schedules in Smartsheet and ensure timely completion of projects with appropriate quality.
• Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
• Contribute to system development by defining system and subsystem architectures
• Identify and document system hazards, failure modes, and risk mitigations
• Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
• 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.
• Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders
Education and Experience:
• Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required,.
• A minimum of 8 years’ experience working in the Medical Device space: in a multidisciplinary project team environment.
• 4+ years of experience in leading a cross-functional engineering teams.
Minimum Requirements:
• Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering
• Experience with root cause analysis using six sigma methodologies
• Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
• Experience writing verification plans, protocols and reports in a regulated industry.
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• Excellent project management skills; experience and capability in leading a cross-functional teams that include development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
Preferred Skills and Competencies:
• Master of Science degree is desired; System Engineering training and/or certification is a plus
• Six Sigma Certification Black Belt or Green Belt certification
• Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.
Physical Requirements (if applicable):
• None
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $132,500.00 - $199,100.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
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.
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What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
