Sr Manager, Dialyzer Product Development
PURPOSE AND SCOPE:
Participates in research and development and leads a development team working on innovative products and improvements to current products. Acts as primary point of contact and leader for project teams in relation to managed products. Develops detailed engineering specifications for major engineering projects.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Project manager and team leader for multiple long term projects with high scientific level. Responsible for development of products from the concept stage through volume production.
- Manages department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods, and staffing.
- Plans, organizes, coordinates, directs, tracks and executes projects with clear objectives and timely deliverables.
- Conducts individual project post mortem meetings in order to ensure that all deliverables met or exceeded expectations, wrap up outstanding project details and declare project complete.
- Interacts with other functions within the company: with Manufacturing on process transfer and support, with Marketing on customer needs, and with QS/RA on product quality and regulatory requirements.
- Assure compliance to corporate policies and local standard operation procedures as well as domestic and international standards.
- Participates in cross-functional teams on new product development and manufacturing problem-solving efforts.
- Seeks and interacts with outside consultants, if needed, on project related technical matter.
- Contributes to the generation of ideas and potential inventions to be used in new products.
- Prepares patent disclosures, journal publication submissions, and presentation abstracts. Assists Patent Lawyers with development of patent documentation.
- Keeps abreast of relevant technology through literature and conferences.
- Supervises and directs activities of group members.
- Responsible for development of products from the concept stage through production transfer including specifications.
- Develops detailed engineering and scientific specifications for major engineering projects.
- Provides technical support to other departments.
- Determines equipment needed within the department and seek to acquire it. See that equipment is properly maintained and improved as needed. Maintain a safe working environment and document safety activities.
- Develops qualification test plans.
- Maintains thorough lab notebook and design history files.
- Writes engineering reports, feasibility reports, and monthly reports.
- Prepares project proposals for new projects.
- Maintains good documentation practices for all data forms, protocols, reports, Design History files, and laboratory notebooks.
- Responsible for monthly reports to R&D Department management and quarterly review presentations.
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
- Maintain general housekeeping of working area and plant.
- Provide technical guidance.
- Assist with various projects as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Frequently required to sit. Occasionally required to stand; walk; use hands and fingers to handle,; reach with hands and arms and wear personal protective equipment that may include safety glasses, hearing protection, Smock, etc.
- Must occasionally lift and/or move up to 25 pounds.
- May be responsible for the direct supervision of various levels of Product Development staff.
- Bachelor's Degree required; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS:
- 6 - 8 years' related experience.
- 3+ years' experience as a Manager preferred.
- Demonstrated ability to manage one or more departments.
- Must be familiar with FDA/ISO Design Control regulations and their application.
- Strong analytical, problem solving, critical thinking, organizational, and financial planning skills.
- Strong oral and written communication skills.
- Proficiency with PC's and strong understanding of Microsoft Office applications.
- Must possess excellent team building, training and facilitation skills.
- Must have the ability to communicate ideas clearly and concisely to management.
- Must be able to prioritize and balance multiple projects and priorities.
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.