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.

·       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

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.