Sr. Product Manager, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Lawrence, Massachusetts

Responsible for ensuring that medical device design process addresses market needs. Responsibilities include management and engineering activities, leading cross-functional teams through medical device development processes, from customer needs definition to commercialization. Duties will include:

Facilitate the design, collection and analysis of user research to identify customer needs and market requirements that will translate to inputs for the engineering teamLeads cross-functional teams on product & engineering design and evaluation processes for new medical device product development projects from concept to product launch.Serves as product engineering subject matter expert, providing guidance and/or design expertise to other functional areas;Leads complex medical device product engineering and development projects across all phases of planning, implementation, and production readiness up to commercialization.Ensures that project development plans, processes and activities address relevant engineering process and user requirements to maximize product usability, quality and use-related safety.Participate in collaborative discussions on engineering processes and impact, across all the functional areas (R&D, Marketing, QA/QC, Regulatory, Clinical, Operations, Service and others) as needed to ensure successful project completion and delivery.Creates, optimizes, and drives structured product engineering roadmaps and plans. Sets and meets deadlines with quality deliverables, effectively adapting and modifying plans based on changing conditions or data.Anticipates, identifies, documents, and manages key program risks; proposes and drives appropriate mitigation and contingency plans.Prepares product dashboard and communicates cross-functional progress clearly across organizational boundaries and levels from individual contributor to senior executive.Plans resource requirements and negotiates Core Team resources with R&D functional managers; seeks to control costs and maximize efficiencies.Leads teams to define and prioritize product engineering scope, objectives, and requirements and ensures compliance to applicable standards and guidance.Develop future product engineering strategies that support future product launches leveraging on existing cross-functional team.

Requirements:

This position requires a Bachelor’s degree (or an equivalent foreign degree) in Industrial Engineering, Human Factors Engineering or a closely related field and 3 years of experience as a Human Factors Engineer. Must also have had 3 years of experience (which can have been gained concurrently with the primary experience requirement) working with the following:

New product development in the healthcare/medical device sector;Converting customer requirements to technical specifications;Developing and drafting engineering inputs;.Preparing and proving documentation for FDA submission packages;Performing risk analysis, verification, validation, and designing and executing usability studies;Experience working with relevant quality regulations including 21 CFR Part 820.30, 21 CFR Part 820.40 and IEC 62366-1 and 60601-1-2.

This is a hybrid position working 3 days/week at the company offices in Lawrence, Massachusetts and 2 days/week from home.

EOE, disability/veterans