Senior Director, Medical Delivery Excellence - Fresenius Medical Care Holdings, Inc.

Senior Director, Medical Delivery Excellence, Fresenius USA Marketing, Inc., a Fresenius Medical Care N.A. company, Lexington, Massachusetts

Responsible for execution delivery management and privacy and security lead and test management for digital product development. Will manage development delivery and design implementation within a given scope, budget, and time according to design control processes for medical, non-medical, health software and electronic devices and accessories in medical environments. Specific duties include:

• Oversee the harmonization of managed delivery execution processes, including workflow, priorities, standards and deadlines;
• Manage stakeholder relationships and cross coordination/communication with Verticals (Product Owners, Tech/Ops, Production, Risk Management, Product Center Management, Regulatory Affairs);
• Oversee the establishment and execution of design and development plans for medical and  non-medical solutions, and for the development of electronic accessories in the medical environment while accountable for the portfolio of project release success;
• Ensure a consistent and transparent way of effectively identifying, managing, and addressing risks during the design planning, development, verification and validation phases up to product transfer activities;
• Consolidate project release reporting for various product developments;
• Lead delivery management by effectively applying the quality system while complying with Standard Operating Procedures;
• Control and direct timing, budget, and scope for product development projects;
• Manage the complex project scope for involved stakeholders, not only by overseeing the functional/user requirements, but also by overseeing the cross functional and technical requirements and managing work packages, people, resources, materials and other factors;
• Coordinate with team of Product Owners, including other medical delivery managers to form a joint command center to run projects for product releases;
• Collaborate effectively with the Digital Service Operations team for seamless product deployment and operations;
• Lead the team of digital product focused cybersecurity engineers ensuring cybersecurity planning, assessments and requirements are determined, establishing security testing approaches as well as establishing a post market surveillance practice to cope with future addressed cybersecurity risks or identified vulnerabilities;
• Implement and drive a harmonized a holistic test approach across all digital product development; and
• Establish a state-of-the-art software development test approach that includes unit testing, automation and tool supported code quality checks from a lower level up to full test concepts and execution for covering regression, performance, nonfunctional, manual and explorative testing.

Requirements:

Position requires either (i) a Master’s degree (or an equivalent foreign degree) in Business Administration, Information Systems or Information Technology and 3 years of experience as an IT Project Manager or (ii) a Bachelor’s degree (or an equivalent foreign degree) in Business Administration, Information Systems or Information Technology  and 5 years of experience as an IT Project Manager.  Experience, which can have been gained concurrently with the primary experience requirements above, must include 3 years of experience working with the following:

• Software verification and validation activities for software applications used in medical devices;
• Applying and working with ISO 13485, 21 CFR 820, 21 CFR Part 11 and UL2900 standards for Cybersecurity;
• Windchill as a product lifecycle management tool and maintenance of Design History Files; and
• MS Project.

Must have strong written and verbal communication and project organization skills. 

This is a hybrid position working 2 days/week in the office located in Lexington, MA and 3 days /week at a home office.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.