SCIENTIST

General Position Summary

As a member of the Tissue Based Research (TBR) group, the Scientist will participate in, and with time drive/manage, new product development as well as product design updates. This role will include responsibility for the design and development aspects of projects through all phases of the product development process, as well as assisting with the planning and executing of product launch, commercialization, and post market surveillance. The ideal candidate for this position has had experience leading/managing medical device design and development activities, with emphasis on new product introduction, research and development, and design/manufacturing transfers.

Areas of research and development may include any of Sakura's anatomic pathology product lines. As such, the successful candidate is expected to learn the function and operation of all Sakura instrument systems and tissue fixation, processing, embedding, sectioning, and staining methods.

Essential Job Functions

Product Development Activities

• Conceives original ideas for new products/product improvements, works to introduce them into practice.
• Develops and refines product solutions by defining requirements, generating concepts, and demonstrating concept feasibility and functionality.
• Provides project management support to TBR development projects as required.
• Ensures designs meet and exceed product specifications, regulatory requirements and international standards, cost, quality, manufacturability, usability, reliability, etc.
• Shows proficiency in the application of design controls and development processes and supports project management functions such as scope definition and prioritization.
• Researches and analyzes scientific & technical information, including intellectual property. Translates the results & conclusions of this work into patentable ideas/proprietary technology and tangible product development activities.
• Understands and evaluates complex scenarios and makes recommendations to management regarding product development decisions.

Work Activities

• Develops experiments, product ideas, concepts, and product development paths based on structured, scientific, and engineering approaches. Develops creative ideas and applies out-of-the-box thinking.
• Works with external collaborators on complex scientific/technology/development projects.
• Meets Operations budget.
• Evaluates data from instruments and experiments using statistical methods and a scientific/engineering-minded approach. Draws conclusions based on data and objective results from scientific evidence and calculations.
• Exercises independent judgment in planning, organizing, performing, coordinating and/or directing product development work. Makes data-driven decisions.
• Prioritizes tasks by distinguishing urgent from important tasks and assesses cost/benefit trade-offs.
• Conducts feasibility and other studies regarding new and modified designs.
• Identifies and resolves technical and commercial challenges to meet aggressive, new-product delivery timelines.
• Maintains detailed documentation throughout all phases of research and development.
• Identifies, qualifies, and implements relevant new technologies and experimental procedures.
• Works with management to formulate project plans and timelines.
• Works in a multi-disciplined scientific environment.
• Provides troubleshooting for instrument and reagent related problems.
• Participates on task forces and business or technical meetings.
• Performs other duties and projects as assigned.

Leadership, Communication, Responsibility

• Manages design projects, identifies and mitigates high-risk tasks, communicates schedules to stakeholders, and drives projects to completion in a timely manner.
• Collaborates with cross-functional stakeholders throughout the development process, negotiates timelines and deliverables.
• Leads effective communication efforts with internal and external stakeholders regarding status, timing, budgetary, and design issues that impact the project.
• Leads design reviews and ensures on-time completion of Design Control deliverables.
• Presents technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations and other means of communication.
• Keeps senior management informed by creating meaningful report summaries of development activities on a regular basis.
• Builds and maintains effective relationships with internal and external stakeholders.
• Provides technical and project related direction and instruction to product development team members.

Quality/Business Systems Activities

• Participates in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives.
• Adheres to technical compliance and risk assessment/management practices.
• Follows GLP and GMP Guidelines.
• Is in compliance with all applicable environmental, health, and safety regulations.
• Participates in audits.

Information Management & Reporting Activities

• Provides clear and concise technical information in experimental notebooks.
• Keeps senior management informed by creating meaningful summaries of developmental results.

Other Skills

• Interacts with supervisor and team members in a professional and proactive manner.

Essential Job Requirements

Education

• Ph. D. degree in Chemical Engineering, Biomedical Engineering, Bioengineering, Biotechnology, the Biological or Medical Sciences, or related subject area; an M.S. degree combined with experience may be considered.

Experience & Minimum Qualifications

• At least 1-2 years of experience with a PhD degree or 5+ years of experience with a MS degree in an academic or professional environment.
• Preference is given to (at least some of) this experience having been gained in the medical device, pharmaceutical, or FDA regulated laboratory environment.
• Demonstrated experience as a technical lead for product development (or similar) activities is a plus.
• Experience in the area of pathology, immunohistochemistry/immunofluorescence, histology, biotechnology, or reagent optimization is a plus.
• Ability to adapt to changing business requirements by adjusting project plans as needed.
• Data analysis experience with proficiency in analytical tools such as R, Minitab, Python, etc.
• Working knowledge of principals of statistics.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Effective planning and organizational skills in order to independently drive product development and improvement projects.
• Requires clear and concise verbal and written communication skills; good technical writing skills; attention to detail; good computer skills (Microsoft Word, Excel, etc.).
• Excellent analytical, organizational, and problem-solving skills.

Physical Requirements & Working Environment

• This position requires the employee to work in a laboratory environment. It involves frequent walking, standing, and sitting. In addition, the employee is required to use hands and fingers and reach with hands and arms.
• Must be able to occasionally lift and/or move up to 50 pounds.
• Ability to successfully respond to multiple work pressures.
• Requires reading, math, analyzing and drawing conclusions from data; developing and implementing methodologies/plans/processes for accomplishing a goal.

"Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law."

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.