Insulet Corporation Looking for Director, Global Equipment Engineering (On-site) Full Time

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:

This role is responsible for vendor selection, development, testing, installation, and validation of fully-automated line for manufacture of Insulet’s Pod. Responsibilities: cover management of selected vendors processes and ensuring proper compliance with Insulet Quality System requirements. Will interface closely with Product Development Engineers, Manufacturing Engineers, and Sustaining Engineering to ensure close coordination of existing knowledge base.

This role is responsible for establishing global programs supporting Insulet’s development initiatives worldwide, and coordinating a global manufacturing automation roadmap to ensure development of standardized automation machinery, equipment, and processes. This individual will establish the key requirements in New Product Development/New Product Introduction that will ensure the highest degree of design for manufacturability and assembly (DFMA), and establish the processes, documentation and training required for the program to become a Best-in-Class manufacturing practice.

Responsibilities:

• Responsible for integration of equipment components to ensure efficient productivity of manufacturing lines. Ensures that equipment engineering projects, initiatives, and processes are in compliance with established policies and objectives.
• Assists in the development and execution of the strategic plan to achieve short and long term business objectives.
• Reviews project activities and provides technical expertise and guidance. Provides regular status and updates to staff and executive team on project/program deliverables.
• Supports operations in establishing the equipment requirements needed to deliver against the site operational goals and objectives including process validation. Establishes specifications for new equipment or modifications associated with improvement of existing equipment.
• Allocate resources, assign priorities to tasks, and acts as an advisor to senior management in delivery of value-added services for Engineering. Manages budgets and contract resources.
• Develops robust and sustainable systems and programs to ensure proper transfer of product and process knowledge between development and manufacturing to achieve product realization.
• Accountable for the technical quality of engineering deliverables in support of technology transfers and projects.
• Accountable for development of technical subject matter expertise and provision of adequate engineering resources (internally and externally) to ensure system reliability, robustness, and maximum availability.
• Implements global programs for Manufacturing Automation and Design for Excellence. Establishes systems, policies, and procedures that define these programs, and ensures full integration at Insulet’s manufacturing and development sites. Oversees complex automation projects and ensures the most appropriate technological and cost-effective solutions.
• Directs team to assess current state of Automation programs in the WW Manufacturing organization. Goals are to identify organizational strengths in automation application and development, and establish standards for manufacturing automation with respect to materials of construction, design specifications, configuration, integration, and implementation of process control solutions, capacity assessment, PLC, HMI, and SCADA systems, etc.
• Identified automation opportunities and develops automation solutions using established standards. Determines if automation solution should be fabricated internally or externally. Develops proposals that demonstrate Return on Investment in a consistent, standardized approach. Performs analysis post implementation of automation to verify savings and refine ROI approach based on learning.
• Establishes annual business plans for the operation, including tactical goals and action plans.
• Develops and fosters effective working relationships with key stakeholders, both internal and external to the organization. Collaborate with stakeholders in support of manufacturing to establish user requirements associated with new equipment purchases and/or modifications.
• Partner with stakeholders, team members, equipment design vendors, and various internal resources in support of sustaining and growing the business model. This includes product, facilities, equipment, supply chain, services, staffing, operating procedures, policies, and standards.
• Establishes all user requirements associated with the design of new production lines including individual pieces of manufacturing equipment.
• Works collaboratively with R&D in the establishment of equipment required for the production of new products.
• Contributes to the development of company engineering priorities, long term strategies and goals. Responsible for integrating production lines.
• Establishes all specifications associated with new equipment.
• Oversees change control associated with modifications to existing equipment.
• Ensures compliance with FDA, OSHA, and other regulatory agencies as appropriate.
• Supervises and directs contract personnel and outside vendors in the performance of contracted services.
• Perform other duties as assigned.

Education and Experience:

• Bachelor’s degree in Engineering, Manufacturing, or a related field and/or equivalent combination of education and experience.
• Experience with manufacturing automation machinery, including equipment design and specification, I/O/PQ, and documentation requirements for cGMP facilities is required, and knowledge of HMI, SCADA, and PLC Systems and design is desirable.

Minimum Requirements:

• Understanding of quality by design, statistics, and its application in engineering.
• Knowledge of GMPs, both basic and unique, to the department’s specialty(s) area.
• Knowledge of statistics (SPC, CPK, AQL, etc.).
• Excellent understanding of manufacturing methods related to the department specialty(s) area.
• Previous technical and management experience (8+ years) in a manufacturing operation, preferably within a medical device or related industry.
• Minimum of 5 – 7 years demonstrated and successful performance/experience in an applicable engineering supervisory or management position.

Preferred Skills and Competencies:

• Ability to communicate effectively with internal and external customers and stakeholders.
• Ability to work effectively in a matrix environment where some functions are shared.
• Motivation and team building skills.
• Ability to supervise all levels of personnel.
• Ability to constructively analyze, challenge, and propose alternatives to complicated technical issues and personnel issues faced by staff.

Physical Requirements:

• Approximately 30% domestic and international travel.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

The US base salary range for this full-time position is $171,840.00 – $249,165.00. 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.

This role works in a healthcare setting subject to the Centers for Medicare and Medicaid (CMS) Vaccination Mandate. This mandate requires employees to be fully vaccinated against COVID-19 unless approved for a medical or religious exemption.