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Hitachi

Hitachi Chemical Diagnostics, Inc. Hitachi Chemical Diagnostics, Inc.

Jobs

Title: Assistant Project Manager
Reports to: President/CEO or R&D Manager
Department: Research and Development

General Summary/Objective (Purpose of position)

The Assistant Project Manager will be responsible for effectively managing detailed projects in the development and commercialization of medical device and IVD Instruments.

Essential Duties and Responsibilities

  • Assist or Lead in the development and commercialization of medical device and IVD Instruments (i.e. AP3600, CLA-2) to commercial launch through completion of clearly established milestones
  • Develop and effectively manage a detailed project schedule to include tracking scope, changes, progress, resources and budget allocation.
  • Work closely with team members for timely delivery of assigned projects.
  • Report and escalate potential issues to management.
  • Develop objectives for each functional area, synthesize functional plans and identify critical interdependencies.
  • Conduct and encourage frequent formal and informal communication within the team to ensure full engagement and efficient operation.
  • Lead the cross functional development of the product architecture and drive successful execution.
  • Evaluate alternative development options to reduce time to market and minimize commercial and technical risk.
  • Actively support the commercial launch of the final system to the market and marketing during post-launch surveillance.
  • Ensure compliance with HCD quality policies, procedures, and practices.
  • Ensure compliance with all local, state, federal, and HCD safety regulations, policies, and procedures.

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)

  • Effective communication skills in English and Japanese – Ability to communicate effectively with US Team and Japanese Instrument Manufacturer.
  • Successful completion of at least 1 medical device project with outsourced engineering and/or production manufacture.
  • Experience planning multiple work-streams, identifying risk and implementing action plans to optimize time lines and reduce execution risk.
  • Experience establishing customer requirements from defined needs specifications and translating to product requirements.
  • Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.
  • Ability to work independently and within a team.
  • Ability to travel approximately 30% of time (Domestic and International).

Education and Experience

  • Bachelor’s Degree in a technical field such as Systems Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering or a closely related technical degree required. Master’s Degree (preferred).
  • Minimum 5 years of experience in R&D/instrument development (medical device or IVD instrument preferred).
  • Experience with FDA regulated Medical Device Industry.
  • PMP certification or equivalent is preferred

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

  • Laboratory and office environment

Physical Demands

  • Ability to sit or stand for long periods of times. (up to 2 hours at a time and up to 8+ hours in a day).
  • Ability to view monitor and use mouse and keyboard for long periods of times. (up to 2 hours at a time and up to 8+ hours in a day).

Position type and expected hours of work

Full Time

Travel Demands

Ability to travel (Domestic and International) up to 30% of working hours.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice to support company requirements.

Additional Information

Affirmative action plan/equal employer opportunity (AAP/EEO) statement

Hitachi Chemical Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Hitachi Chemical Diagnostics, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Disclaimer

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Hitachi management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.