Our client, one of the largest pharmaceutical companies in USA is looking for Scientist - I (Assistant) to work at West Point, PA. **Job Title:** Scientist I - Device and Combination Product Test **Duration:** 12 Month Contract **Location:** Onsite - 126 E. Lincoln Avenue PO Box 2000, Rahway, NJ 07065 **Must haves:** + **Analytical engineering** + **Mechanical testing expertise** + **Lab experiments experience** + **Familiar with test methods, Method development and method validation.** **Red Flags:** + Major gaps + jumpy job history **Qualifications:** **Education Requirement (minimum):** + B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required. **Required Experience and Skills:** + **A minimum of M.S., or B.S. plus 1-3 years of design, engineering, and mechanical testing/test method development experience.** + **Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.** + Experience training junior staff on instrumentation operation and data analysis/interpretation best practices. + **Deep technical understanding of test method development and qualification/validation techniques.** + **Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.** + Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing. + **Experience in 3D CAD (e.g. SolidWorks), geometric tolerancing and stack-up analysis.** + Documents (following Good Documentation Practices) and analyze test cases and provide comprehensive feedback and recommendations for product or design changes. **Preferred Experience and Skills:** + Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex . Keyence / Cognex), Bouncer, and drop shape analyzers. + Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensure measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle. + Experience with medical device development with understanding of Design Controls (21 CFR 820.30) + -Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use. + Additional familiarity/experience with the following industry related knowledge is a plus: + 21 CFR Part 4 + 21 CFR 211 + FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics + ISO 13485 + ISO 14971 + ISO 11040 + ISO 10993 If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.