Scientist, Quality Engineering, Research Scientist

Onsite - Arbor Lakes Job Purpose

The Scientist I has engineering/science education, a basic technical skill set, and the ability to work in a team setting. Applies engineering/scientific skills and commitment to quality to execute experiments and complete data analysis in support of projects. He/she is gaining knowledge in scientific/engineering concepts, business practices, and core business principles.

• Remains knowledgeable of technologies (including relevant literature) within the functional area.
• Supports testing of new technologies and targets for research within the functional area.
• Generates data to support posters, presentations, and internal documents.
• Utilizes knowledge of legal boundaries surrounding information sharing and documenting; may contribute to brainstorming for intellectual property.
• Develops an understanding of experiments/protocols (e.g., DOE) and design process; executes under direction; completes routine work independently within functional area.
• Applies basic data analysis; develops understanding of more complex data analysis; identifies basic problematic issues with data; compares results with historical data.
• Summarizes results, contributes to the generation of technical reports, and completes experimental paperwork/lab notebook documentation.
• Develops methods and processes under direction from senior technical staff.
• Participates as an extended team member for experimental execution.
• Performs assigned routine experimental techniques and processes according to the functional area.
• Orders supplies and may submit sample requests as directed by more senior staff and per the SOP.
• May perform equipment maintenance and generate and execute equipment IQ/OQ as needed.
• Adheres to all EH&S procedures and general housekeeping SOPs.
• Complies with site and department-specific procedures on record keeping, use of log books, materials receiving, and inventory control.
• Completes time records and reports project-allocation time.
• May participate in implementing solutions for lab/infrastructure improvement.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• For those individuals who supervise others, the following statements are applicable:
• Assures that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• BA/BS degree in Biology or Chemistry (or a related Engineering field)
• 2+ years of medical device experience
• Self-motivation with a passion for solving problems
• Hands‑on approach to method development
• Ability to communicate complex ideas clearly and simply, both orally and in writing
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline‑driven environment
• Team player with excellent interpersonal skills
• Computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
• Prior experience in test documentation through lab notebooks or reports.

• Test Method development experience
• Knowledge of Minitab.
• Competent in Design of Experiments methodology (i.e., Design-Expert), scientific method, and statistical analysis software (i.e., Minitab)
• Strong problem‑solving skills.
• Demonstrated experience analyzing and fulfilling documentation requirements.
• Experience in the medical device industry, preferably testing medical devices.