Summary:
Responsible for driving program execution of various medium to large projects. Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan. This role leads across the Core Team to continuously integrate for predictable execution and teamwork across all functions.
Responsibilities:
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.
Qualifications/Requirements :
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
Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies
MS Project, One Pager, MS Teams, Smartsheet experience a plus
Must Have Skill Sets:
Project management
Product Development
Experience with design controls and medical device regulations
Drug delivery/combination product experience
Risk based process
Presentation skills
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
• AditiConsulting
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