As a Senior R&D Engineer, you will develop new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, you will develop, direct, and execute plans for a major segment of complex projects. You will compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
Key Responsibilities:
1. Lead or support workstream activities on Next Generation calcium products ensuring product safety, compliance, and performance improvements.
2. Support marketing in gathering customer feedback on next generation products.
3. Conduct product demonstrations at conferences.
4. Engage in early conceptual work as part of exploratory efforts in the calcium space.
5. Develop pilot processes and equipment, including process design and development, preparation of specifications, process capability studies, six sigma process testing, report preparation, process/test documentation, and transfer of processes from pilot to manufacturing.
6. Work independently to plan and schedule activities necessary to meet timelines.
7. Lead or participate in a cross-functional team to troubleshoot new products/process problems related to design, material, or process.
8. Summarize, analyze, and draw conclusions from test results.
9. Prepare standard reports/documentation to communicate results to the technical community.
10. Be responsible for engineering documentation.
11. Train and/or provide work direction/supervision to technicians.
12. Work cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing teams to ensure project success.
13. Communicate changes in project milestones and write project reports as required.
14. As a member of the development team, you will have a significant impact working within the development process to bring products/processes from concept to commercialization, applying Exploratory, Technical Development Process (TDP), and Product Development Process (PDP) methodologies.
15. Provide technical guidance within a large team and be an effective communicator within a multidisciplinary and international organization.
16. Evaluate, in conjunction with EHS, new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
17. Ensure regulatory compliance to GMPs of all medical device regulatory agencies (e.g., FDA, ISO, and MDD).
18. Flexibility to travel to the US and Europe.
What we’re looking for:
1. Bachelor’s degree (240 credits) in a scientific or engineering discipline (STEM), preferably Mechanical or Biomedical.
2. Minimum 6 years of experience, preferably in R&D.
3. Availability for international travel when required.
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