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Who we want: This position is responsible for project managing (scope setting, project planning and execution) the implementation of all manufacturing processes and associated supply chain systems to support the development and commercial launch of new product programs on time, within budget and to required performance requirements.
Working within the medical device quality management system, this leader manages a cross-functional team of professionals promoting collaboration and alignment within the team while simultaneously interfacing with both Commercial and Operational leaders to maintain organizational alignment through stakeholder management.
What you will do: 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 Qualifications: Bachelor's degree in a Polymer Chemistry, Chemical Engineering, /Materials Science/ discipline or equivalent Minimum of 8 years engineering / project experience in a regulated industry essential Preferred Skills: Experience small batch mixing and filling – syringes is a plus Ability to lead, motivate and influence a cross-functional team on projects that does not report directly to this position Strong communication and interpersonal skills with the ability to express ideas and collaborate effectively with multi-disciplinary teams Excellent analytical and problem-solving skills including risk management experience. Experience in process validation Experience with delivering results through six sigma and lean methods Experience with MS projects PMP or equivalent preferred About Stryker Our benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
