We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients' smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves - their best selves - to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie - we hope you'll consider being a part of it!
Sr. Research Engineer 1 (Chemistry) (Palm Beach Gardens, FL): Develop a strategy to conduct clinical evaluation of medical devices through systematic searches, screening and appraisal of peer-reviewed publications, biocompatibility data, complaint analysis, design control and risk management documentation (e.g., design verification/validation protocols and reports, risk management reports) in compliance with the EU MDR; create clinical development plan, clinical evaluation plan, clinical evaluation report, and summary of safety and clinical performance in compliance with the EU MDR; assist in the development of wet chemistry research and testing project plans pertaining to implant surface modifications: This includes developing project timelines, and deliverables; prepare samples and solutions for analysis, ensuring accuracy, precision, and compliance with established protocols and procedures; perform routine and non-routine analytical tests on raw materials, in-process samples, and finished products using various analytical techniques; collaborate with research and development teams to transfer methods from development to manufacturing; assist in troubleshooting analytical issues and recommending solutions; assist in development of new chemical formulations, analytical methods, and test protocols, including designing and implementing test protocols, selecting the appropriate test equipment, and interpreting test results; provide timely and accurate reporting on project progress and completion, including writing reports, creating presentations, and communicating with stakeholders; and direct, coordinate, or advise personnel in test procedures for analyzing chemical composition or physical properties of materials.
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Requires a bachelor's degree in Chemistry, Research, Engineering or related field, or foreign equivalent. Requires 5 years of experience in job offered or related field.
Requires experience with:
- performing product inspections and generating verification and validation reports, working as a supplier quality engineer on manufacturing floor, and working closely with design engineers on improving the efficiency of product development process, pertaining to dental Implants/Instruments, non-invasive diagnostic equipment and/or Surgical Robotic Arm;
- performing clinical evaluation tasks including but not limited to 1) creating, reviewing and summarizing verification and validation protocols and reports, 2) analyzing and leveraging these reports along biocompatibility and preclinical testing reports, and risk management files for defending the safety and clinical performance of dental instruments, surgical and restorative medical devices, 3) identifying source documentations required for defining clinical evaluation strategy and working on clinical evaluation plan creation;
- performing dental device clinical evaluation tasks according to EU MDR, MEDDEV guidance and MDCG guidance and ISO standards;
- performing non-invasive diagnostic device related research and lab testing according to GLP and GMP requirements and conducting and producing reports on blood testing data per clinical trial protocol.
Role requires up to 15% domestic and international travel. Role permits up to two days remote work per week.
Any applicant who is interested in this position may apply to Biomet 3i, LLC via email at hroperations@zimvie.com (please reference job # MB679918).
Proof of authorization to work in U.S. is required if hired. The company is an Equal Opportunity Employer and fully supports affirmative action practices.
ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.
ZimVie generally does not sponsor applicant work visas for this position.
- Requisition ID: 2825