Sr. Project Manager, R&D

Job Summary:

Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability

Essential Duties & Responsibilities

• Sets the manufacturing strategy for the project gaining alignment with both Commercial and Operational leaders.
• Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management and DFM (Design for Manufacture).
• Provides strong, capable leadership to the project team encompassing of key professionals from Quality, Sterilization, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables.
• Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialization from the design development phase.
• Develops a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums.
• Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.
• Supports supply chain strategy execution in collaboration with Global Quality & Operations partners and drives timely completion of sourced component qualification processes (PPAP) in alignment with QMS requirements.
• Determines demand requirements and implements manufacturing capacity solutions in support of early product/process development, design/process validation builds and product launch activities.
• Drives implementation of Lean Manufacturing throughout the project phases through to launch.
• Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations and ensuring timely installation, qualification and validation efforts.
• Identifies and escalates unresolved obstacles to the success of the project. Leads resolution of problems that impede project progress.
• Establishes project priorities, imparting a sense of urgency and importance to the team while using project management tools and techniques to support delivery of project imperatives.
• Participates in the selection, training, and performance appraisal process of project resources, including temporary contract SMEs, as required.

Minimum Requirements:

• B.S. in Engineering or Science discipline or equivalent
• 6+ years’ of years engineering / project experience in a regulated industry essential.

Preferred Skills:

• Mechanical or biomedical; MS and/or MBA
• Medical Device or other regulated industry
• Ability to successfully plan, prioritize, multitask and organize multi-disciplinary team(s) to successfully achieve project deliverables
• Worked in a manufacturing setter
• Prior experience working with Suppliers and Contract Manufacturers.