Sr. Project Manager, Manufacturing Engineering (On-site)

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 Project Manager, Manufacturing Engineering is responsible for overseeing and driving manufacturing expansion and improvement efforts. This role involves managing resources, milestones, budgets, and communications for various manufacturing projects, ensuring efficient and effective project execution.

Responsibilities

• Monitor and coordinate manufacturing expansion and improvement projects from concept through implementation, ensuring alignment with business goals and timelines.
• Facilitate new product introduction (NPI) initiatives,  supporting design transfer activities and supporting manufacturing scale-up processes.
• Track and support Design for Manufacturing (DFM) efforts, ensuring component selection and design are optimized for manufacturing ease and cost efficiency.
• Identify and manage resources, set project milestones, and ensure timely completion of project phases.
• Develop and manage project budgets, ensuring cost-effective use of resources and adherence to financial constraints.
• Oversee project execution, control, and tracking to ensure projects are completed on time and within budget and ensure effective project risk management to mitigate potential issues.
• Facilitate clear and effective communication with team members, leadership, and vendors to ensure project alignment and progress.
• Maintain project documentation, prepare status reports, and manage communication of project updates to team members and leadership.
• Work closely with cross-functional teams to identify project needs, develop project plans, and ensure successful project execution.
• Identify potential risks and develop mitigation strategies to ensure project success.
• Manage relationships with vendors, ensuring timely delivery of materials and services required for project completion.
• Ensure all project work complies with FDA regulations, ISO 13485:2016, Good Manufacturing Practices (GMP) and other relevant industry standards and regulations.
• Oversee progress of design control and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) protocols and reports.
• Adapt to a fast-paced manufacturing scale-up environment, ensuring rapid and efficient production ramp-up.

Key Decision Rights

• Generate and publish project plans, timelines, resource plans and budgets to ensure alignment with business objectives and resource availability.
• Propose and enact risk mitigation strategies and implement necessary adjustments to project plans to address potential issues.

Required Leadership/Interpersonal Skills & Behaviors

• Excellent written and verbal communication skills.
• Ability to communicate effectively at all levels of the organization.
• Desire to work in a fast-paced environment and ability to adapt to changing priorities.

Required Skills and Competencies

• Proficient project management skills, including the ability to prioritize multiple timelines and tasks.
• Proficiency in project management software (Jira, MS Project, Smartsheet, etc.), Microsoft applications.
• Experience with AutoCAD, SolidWorks, Minitab, and other engineering applications (preferred).

Education and Experience

• Bachelor’s Degree in Engineering (Mechanical, Industrial or Manufacturing preferred), or a related field.
• 5+ years of experience in manufacturing engineering or related fields.
• 3+ years of project management experience in a manufacturing environment.
• Experience in the medical device industry and supporting product development/new product introduction (required).
• Experience in high volume manufacturing (preferred).
• Strong analytical skills, attention to detail, and excellent interpersonal skills.
• Knowledge of industry standards and regulatory requirements.
   

Additional Information

• Estimated travel (domestic and international) is approximately 10% per year.
• This position will be on-site in Acton, MA.

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

Additional Information: