Job Description

• Lead medium/small projects independently and work directly with Program Manager on large multi-year programs.
• Managing the overall program including creating and maintaining the project schedule, identifying and mitigating program risks, driving program task execution, and co-leading regular core team meetings.
• Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
• Co-Leads the cross-functional Program Core Team to establish an integrated plan for resources and materials to deliver the new product program per the Product Delivery Team commitment.
• Identifies early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals, execution adjustments/iterations, and cross-functional teamwork.
• Works with the Program Manager to ensure effective and efficient communication and execution for the duration of the cross-functional program team.
• Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget and with the necessary features/functionality.
• Works with the functional engineering leadership team to grow project leadership skills within the Core Team
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers.

• Project management, design controls, drug delivery experience, risk based process
• Combination of product or medical device development experience.
• Nice to have: Mechanical testing experience.

• Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience
• Medical device and/or combination product development experience; design controls experience
• 4+ years' experience in project leadership in engineering product development, manufacturing or research environment, including previous leadership of a global and/or virtual team.
• 5+ years of more progressive responsibility and experience as an engineer or scientist
• Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills