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

Job Title: Senior Project Engineer, R&D

Department: R&D

FLSA Status: Exempt

Position Overview:

The Senior Project Engineer, R&D is responsible for the project management of lifecycle engineering projects through a methodical approach of planning, executing, and controlling projects from start to finish. The Senior Project Engineer would demonstrate project ownership and guide teams through project execution process while translating strategic objectives to an execution level. Helps ensure consistent practices throughout all phases of the project life cycle and across project functional teams. Use professional project management concepts and frameworks in accordance with company objectives to solve complex problems in a creative and effective way. Exercise a balance of independent judgment and group organization in developing methods, techniques, and evaluation criteria for obtaining results.

Responsibilities:

• Effectively lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements.
• Maintain and monitor project budgets, directing the efficient use of resources to effectively complete projects.
• Lead project-related activities of project team members, providing guidance on conformance to established design control procedures.
• Prepare project summary reports, develops project plans, identifies risk, and communicates mitigation activities.
• Prepare and deliver project status presentations to Management regularly.
• Lead and/or participate in all phases of development starting with concept through design transfer, including VOC, design input development and obtain required approvals for design input and design output required documentation working with Commercial and RA/DA/QA.
• Participate in and/or oversee all design and process validation activities required for assigned projects.
• Adhere to all regulatory agency standards, company quality standards and corporate policies.
• Must be able to travel domestically and internationally as business needs demand.
• Perform other duties as required.

Education and Experience:

Minimum Requirements:

• Bachelor’s degree in electrical/Mechanical/Computer Engineering
• At least 10 years of overall work experience in a technical discipline and 5 years of demonstrated experience in an engineering leadership/program management role
• Medical Device Experience
• Experience with Design Controls
• Strong organizational and communication skills (written and verbal)
• Proficient in the following computer software applications: MS Office products, Outlook, Word, Excel, PowerPoint, and Project.

Preferred Skills and Competencies:       

• M.S. or equivalent degree in an Engineering/technical discipline
• Demonstrated skills in commercialization of FDA regulated medical devices (Class 1, 2 or 3) using design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization.
• Medical Device Program Management experience
• Agile/SAFe experience
• Knowledgeable of the US and International Medical Device and Drug Delivery Regulations
• Knowledgeable about Software development
• Project management certification preferred.

Physical Requirements (if applicable):

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 $97,575.00 - $146,362.50. 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.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and oth