Position: Scientist 2, Chemistry

Location : Tempe, AZ

Duration : 12+ Months contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Onsite mainly but some travel / remote work could be included.

• 5 Must haves on the resume: These are the key skills / experience that we need the individual to have.

- Skilled in polymer science, physical chemistry or colloidal chemistry
- Know-how in the area of surfactants
- Thorough knowledge of formulation technologies (granulation, emulsion, encapsulation)
- Thorough knowledge of characterization test methods for nanoemulsion ( DLS particle sizing and zeta potential)
- Experience in transfer of products from lab to manufacturing scale

Position Summary:
Primary focus of this position is to support in developing, optimizing, implementing, and validating components/elements of a medical device. The candidate will perform hands-on testing in optimization of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; independently performs midlevel data analysis and simulations; support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):
1. Design: Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Fabricate test materials for engineering evaluation, pre-clinical studies and clinical studies.
2. Process Development: assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation.
3. Documentation: prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Assist in preparing verification and validation protocols and reports.
4. Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians / operators; prepare and assist in the validation of test methods.
5. Testing: perform lab bench and analytical testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities.
6. Training: train technicians / operators on new design and process development as well as new test methods. Assist/conduct new process development training with operations and quality assurance.

Other Responsibilities may include, however are not limited to:
• Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:
• B.S. or M.S. in a scientific discipline such as chemistry, biomedical engineer, or chemical engineer discipline.
• 1-3 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment. Experience in product development is a plus.
• Demonstrated hands-on technical aptitude.
• Excellent oral and written communication skills.
• Ability to work in cross functional teams.
• Ability to think creatively as demonstrated through understanding and interpretation of patents, technology white papers and clinical literature.
• Skilled in polymer science, physical chemistry or colloidal chemistry
• Know-how in the area of surfactants
• Thorough knowledge of formulation technologies (granulation, emulsion, encapsulation)
• Thorough knowledge of characterization test methods for nanoemulsion ( DLS particle sizing and zeta potential)
• Mechanical aptitude and knowledge of engineering principles
• Experience in transfer of products from lab to manufacturing scale
• Demonstrated record of achievement for formulation research and development from discovery to commercialization phases.

Preferred Qualifications:
• Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
• Knowledge of cGMP and GLP is a plus.

Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.