About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

The Project Manager coordinates, plans, organizes and manages material and human resources to drive successful completion of assigned medical device engineering projects. The position defines problems, collects data, establishes facts, and draws valid conclusions to make sound recommendations and decisions based upon cost, customer requirements, regulations and other pertinent data.

The Project Manager ensures that product designs meet specification and function as intended. The position oversees projects through all phases of development to include initiation, planning, design, test, market launch, production transition to NPI, monitoring and closing. The position ensures projects meet project goals on time, on budget, with high quality.

Responsibilities

Ensure projects are consistent with corporate quality and regulatory policies.
Build cohesive engineering project teams and cross functional program teams. Provide the leadership necessary to motivate employees and meet company defined deadlines.
Coordinate and complete projects across functional areas (Marketing, Quality & Regulatory Affairs, Purchasing, Operations). Coordinate with functional management to allocate appropriate human resources based on project needs and schedule for the project.
Identify risks and address corrective actions.
Maintain complete, accurate, and timely design history documentation as required.
Contain product cost through design, process, procedure, and method improvement.
Review product design for compliance with engineering principles, company standards, customer contract requirements, marketing requirements, and other related specifications.
Evaluate and approve design changes, specifications, and drawing releases.
Assist Engineers and Designers with technical input as necessary.
Create comprehensive cross-functional project plans that include conceptual design, specifications, critical path items, FMEA, risk analysis. Collaborate with appropriate functional groups for financial analysis and budget, product cost, tasks, deliverables, schedule as well as product marketing, forecast and launch plans, product production and product service plans.
Manage project teams to comply with medical device design control requirements of FDA and ISO 13485.
Identify and resolve project management issues within the team. Guide the team to plan and schedule project timelines and milestones.
Communicate effectively the project goals and objectives.
Monitor project activities, progress, milestones, and cost to ensure new products release in accordance with company’s long-term strategy.
Report project(s) status on a weekly basis to corresponding departments and communicate with management on a regular basis.
Escalates budget and schedule issues as appropriate.
Train and instruct other members of the department and the company, by passing along skills and information to assist them in their development and advancement either with one-on-one or with platform training skills.
Become an independent employee able to analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality. Make sound and logical decisions and choose the appropriate courses of action based on the parameters of the situation at hand and to use continual improvement problem solving skills.
Create an ongoing effort to improve the Company and the Project Engineering department through personal action and by contributing ideas to support both the department and Company’s ongoing improvement efforts.
Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

Qualifications & Requirements

Experience and education – as outlined below, per job level.
Thorough knowledge of medical device design documentation regulations.
Demonstrated ability to lead specific engineering project teams.
Strong influencing skills; ability and judgment to provide project management direction to the team, to ensure project plan is executed.
Project management experience with responsibility for multifunctional disciplines.
Knowledge in areas of schedule development, cost, scope, system integration, and quality assurance.
Ability to apply principles of logical or scientific thinking to all aspects of the job.
Neat and professional appearance and outgoing people-oriented personality which conveys pride in working for Mizuho OSI and which is demonstrated with a ready smile and a willingness to assist others.
Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, and PowerPoint.
Ability to clearly express oneself verbally in the English language using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees. Ability to communicate effectively with employees and other business contacts in a courteous and professional manner. Excellent verbal and written communication skills, persuasive communication, strong presentation, meeting management, project and organizational skills.
Ability to clearly and effectively express oneself through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling. To be able to prepare business letters, and reports. Ability to perform basic arithmetic functions, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.
Excellent customer focus with a high sense of urgency. Ability to work with a professional and positive attitude to improve processes.
Respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.
Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously. To be able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.
Ability to establish and accomplish goals independently and to function as a positive and productive team member.
PMP Certification is highly desirable.
Knowledge of Six Sigma is a plus.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary: $115,234 - $164,620 + Bonus

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