Senior Project Manager at STERIS Corporation in Montgomery, AL
Position Summary Opportunity to lead and drive New Product Development products from cross-functional team inception to Full Market Release. Directs all phases of medical device program and project development from cross-functional team inception, completion of a commercialized product, launch, post-market surveillance and change control. Organizes and leads cross-functional teams on multiple medical device new product development and change control projects that may include, at varying complexity, the following:
acquisitions; major new products; major and small line extensions; major redesigns; sourcing projects; inter-divisional projects; and value improvement and business continuity projects. The programs and projects managed by the Senior Project Manager represent critical strategic imperatives and are global in both scale and scope, and have direct visibility to Senior Management. The Senior Project Manager is expected to be a strategic, forward thinker, and should be open to learning and implementing new processes and ideas. The Senior Project Manager is expected to consistently find ways to better our processes, improve timeline opportunities, and not be satisfied with the status quo. The recommendations from the Senior Project Manager and cross-functional teams have impact on the division affecting the financial, employee and customer view of the company. What You Will Do:
Serves as a proactive interface between Engineering, Marketing, Clinical, Manufacturing, Regulatory and Quality to ensure effective progression and delivery of projects. Develops and drives the cross-functional plan/strategy as well as execution of new products and change control projects directed by the Value Stream. Provide key program or project leadership with the integration of acquisitions. Provides leadership, mentoring and technical expertise to ensure high quality products for the marketplace are delivered right the first time. Has a 'can-do' attitude and strong customer service approach to internal customers in order to bring team together and get work completed. Ensures the New Product Development and Change Control Project process is followed. Owns the overall program and project management of the product development to ensure targets are met for performance, features, quality, costs, reliability, manufacturability, etc. Creates, monitors and updates project plans. Defends due dates when obstacles arise by helping the team come up with alternative solutions and plans to achieve the end goal. Acts as the primary leader for assigned program and project activities, leading review sessions to discuss project status, critical paths, risks and milestones. Has core knowledge of other job functions to help complete critical path items What You Need To Be Successful:
Bachelor's degree, Technical degree in the sciences or engineering fields highly beneficial; Master's degree is a plus 8-10 years' experience, 5
in program, project or portfolio management associated with product development and change control in a medical device or a regulated industry Experience in more than one of the following disciplines a plus:
Design and/or Development Engineering, Product Marketing, Finance, Manufacturing, Regulatory, Quality Strong project management skills required; PMP certification a plus Experience leading projects from initial concept, through development, 510(k) submission and verification/validation testing, and into Manufacturing through product launch. Ability to balance Customer needs; manufacturing, business and regulatory requirements to expedite launch of the right new product development products and change control projects to market. Experience successfully managing programs and projects through medical device New Product Development and Change Control Project process. Track record of managing projects to schedule and budget. Demonstrated proficiency in program and project management tools and procedures for setting and tracking performance, quality, time and cost; strong planning and organization skills required. Requires knowledge of regulatory environment (Good Manufacturing Practices (GMP) and applicable Quality System Standards). Ability to effectively handle conflict through proactive action, and direct and timely communication. Demonstrated leadership skills including conflict resolution, assertiveness and negotiation skills required. Ability to lead and collaborate within a team-based matrixed organization across all business functions, levels and cultures. Experience in successfully coordinating with functional departments (e.g. Engineering, Legal, Regulatory, Operations, Materials & Logistics, Clinical Affairs, Marketing, Quality, etc.). Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams. Demonstrated critical thinking - ability to make sound data driven business decisions; understand, track, drill down and question activities and issues in all functional areas. Strong attention to detail, follow-through skills and experience to check behind the scenes to ensure surprises are minimized. Excellent written, oral and presentation skills. Sets the standard for timeliness, work ethic, and personal integrity. PC literate; Microsoft Project.
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
acquisitions; major new products; major and small line extensions; major redesigns; sourcing projects; inter-divisional projects; and value improvement and business continuity projects. The programs and projects managed by the Senior Project Manager represent critical strategic imperatives and are global in both scale and scope, and have direct visibility to Senior Management. The Senior Project Manager is expected to be a strategic, forward thinker, and should be open to learning and implementing new processes and ideas. The Senior Project Manager is expected to consistently find ways to better our processes, improve timeline opportunities, and not be satisfied with the status quo. The recommendations from the Senior Project Manager and cross-functional teams have impact on the division affecting the financial, employee and customer view of the company. What You Will Do:
Serves as a proactive interface between Engineering, Marketing, Clinical, Manufacturing, Regulatory and Quality to ensure effective progression and delivery of projects. Develops and drives the cross-functional plan/strategy as well as execution of new products and change control projects directed by the Value Stream. Provide key program or project leadership with the integration of acquisitions. Provides leadership, mentoring and technical expertise to ensure high quality products for the marketplace are delivered right the first time. Has a 'can-do' attitude and strong customer service approach to internal customers in order to bring team together and get work completed. Ensures the New Product Development and Change Control Project process is followed. Owns the overall program and project management of the product development to ensure targets are met for performance, features, quality, costs, reliability, manufacturability, etc. Creates, monitors and updates project plans. Defends due dates when obstacles arise by helping the team come up with alternative solutions and plans to achieve the end goal. Acts as the primary leader for assigned program and project activities, leading review sessions to discuss project status, critical paths, risks and milestones. Has core knowledge of other job functions to help complete critical path items What You Need To Be Successful:
Bachelor's degree, Technical degree in the sciences or engineering fields highly beneficial; Master's degree is a plus 8-10 years' experience, 5
in program, project or portfolio management associated with product development and change control in a medical device or a regulated industry Experience in more than one of the following disciplines a plus:
Design and/or Development Engineering, Product Marketing, Finance, Manufacturing, Regulatory, Quality Strong project management skills required; PMP certification a plus Experience leading projects from initial concept, through development, 510(k) submission and verification/validation testing, and into Manufacturing through product launch. Ability to balance Customer needs; manufacturing, business and regulatory requirements to expedite launch of the right new product development products and change control projects to market. Experience successfully managing programs and projects through medical device New Product Development and Change Control Project process. Track record of managing projects to schedule and budget. Demonstrated proficiency in program and project management tools and procedures for setting and tracking performance, quality, time and cost; strong planning and organization skills required. Requires knowledge of regulatory environment (Good Manufacturing Practices (GMP) and applicable Quality System Standards). Ability to effectively handle conflict through proactive action, and direct and timely communication. Demonstrated leadership skills including conflict resolution, assertiveness and negotiation skills required. Ability to lead and collaborate within a team-based matrixed organization across all business functions, levels and cultures. Experience in successfully coordinating with functional departments (e.g. Engineering, Legal, Regulatory, Operations, Materials & Logistics, Clinical Affairs, Marketing, Quality, etc.). Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams. Demonstrated critical thinking - ability to make sound data driven business decisions; understand, track, drill down and question activities and issues in all functional areas. Strong attention to detail, follow-through skills and experience to check behind the scenes to ensure surprises are minimized. Excellent written, oral and presentation skills. Sets the standard for timeliness, work ethic, and personal integrity. PC literate; Microsoft Project.
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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