RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The R&D Senior Mechanical Engineer will become a key member of a specialist team with a primary focus on designing and developing capital equipment for new product development projects. Daily responsibilities will include mechanical design using SolidWorks, fabricating parts, assembling console builds, analyzing data, documenting processes, planning and coordinating tasks, and collaborating with team members. A strong mechanical aptitude is essential for this role.
Key Responsibilities
- Fully participates in and successfully contributes to project teams, typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and planning/coordination of work.
- Works independently to plan and schedule activities necessary to meet timelines.
- Trains and/or provides work direction to technicians and junior engineers, as necessary.
- Designs and coordinates standard engineering tests and experiments.
- Designs, procures, and fabricates tooling and fixtures.
- Performs troubleshooting on products and process issues related to design, material, or process.
- Summarizes, analyzes, and concludes test results.
- Prepares standard reports/documentation to communicate results to the technical community.
- Invents/creates concepts and designs for new products and processes and submits idea disclosures.
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
- Consult and solicit feedback from internal stakeholders to identify customer needs and translate these requirements into mechanical designs. In addition, it provides support regarding product development to internal departments related to mechanical design.
- Demonstrates product development system knowledge through the delivery of high-quality deliverables.
Requirements
- Degree in Mechanical Engineering.
- 5+ years of engineering work experience with a minimum of 3 years of medical device development experience. Relevant advanced education considered as substitute for work experience.
- Machine design and development experience a plus.
- Highly self-motivated and directed.
- Proven analytical and problem-solving abilities.
- Proficient in SolidWorks.
- Strong mechanical aptitude and broad knowledge of materials.
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
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