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 team
• Leads 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.