Available Openings 1
PURPOSE AND SCOPE:
You will lead product and process development project activities related to NxStage Medical’s disposable products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Lead major projects, or phases of projects, to resolve advanced and complex technical problems
•Delivers appropriate project management processes, methods, techniques, and tools and is able to implement these according to the project’s requirements
•Coordinate, monitor and manage project activities, deliverables, and schedule, ensuring appropriate escalation and reporting of timeline status, delays, blocking issues, risk assessment, budget variances and compliance matters, as needed.
•Accountable for accurate, thorough documentation. Assist with the development and distribution of reports and project documents defining project progress, issues and solutions including but not limited to project plan, communication plan, issues log, risk log, project timeline, and high-level executive summary.
•Lead product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.
•Author and execute product and system specifications, validation and test protocols and validation and test reports
•Lead Risk Management activities including, Fault Tree Analysis and Failure Mode and Effects Analysis activities to ensure design, use, and process shortcomings are identified and appropriately addressed
•Work with Quality Assurance and Research and Development to maintain an approved Quality System that complies with GMP’s, QSR and ISO standards
•Domestic and international traveling (on an as needed basis, up to 20% of total time)
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.
Bachelor’s Degree or advanced degree in Engineering or related field.
EXPERIENCE AND REQUIRED SKILLS:
- 8+ years of experience in medical device product design or manufacturing
- Project Management Certification (PMP) desired
- Experience with ISO 13485 and/or related medical device standards
- Experience with USP/EP/BP, ISO 13408, ISO 10993, ISO 14971 and ISO 11607 Aseptic Processing a plus
- Familiarity with plastic fabrication methods such as injection molding, thermoforming, casting, extruding, solvent bonding, heat welding, ultrasonic welding
- Strong understanding of product and process development of medical devices is required
- Familiarity with analytical methods, stability study design (ICH Q1A) and microbial testing desirable
- Positive can do attitude and strong leadership skills
- Ability to work in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals
- Excellent interpersonal skills with the ability to fluently communicate technical concepts to all levels within the organization
- Ability to manage complexity in a fast-paced environment
- Advanced understanding of entire development process, including specification, documentation and quality assurance
- Experience working with contract manufacturers and/or suppliers, including outside the United States
- Spanish fluency highly desirable
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.
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