About the Role
The Mechanical Design Engineer will develop and support innovative surgical devices, from concept to launch and beyond, with shared responsibility and shared reward. The role of a Design Engineer should be to understand user needs and requirements, balance individual product-level requirements with system-level requirements, resolve complex mechanical design issues, and commit to the highest product quality.
Key Activities
The Design Engineer creates design concepts through vendors of rapid prototyping physical models (3D printing, machining, etc.).
Creates intellectual property by brainstorming novel concepts, writing invention disclosures, and creating rapid prototypes.
Serves as a technical designer, providing technical advice, working on cross-functional project teams to develop new, world-class surgical devices.
Performs engineering analyses of parts and assemblies (FEA, fatigue, manufacturability, FMEA, root cause analysis, DOE creation). Establishes and maintains systems for continuous improvement by capturing user feedback and other data to improve existing and new designs.
The Design Engineer creates and maintains engineering drawings to company and international drafting standards.
Supports the quality and regulatory processes.
Abides by the documentation for product development that aligns with the company's Quality System and meets or exceeds requirements of the FDA's 21 CFR Part 820 regulations and ISO 13485 standards.
Works within the non-conformance system to record discrepancies assists in the review of the non-conformance and to record the results of the Material Review Board (MRB) and associated activities.
The Design Engineer reviews device master records, history records and other quality-related documents for accuracy and completeness. Assists to perform first article inspections.
Performs testing of medical devices to replicate customer complaints for the evaluation of changes to existing and new product designs.
Designs for manufacturing and automation, sterilization processes and biocompatibility.
The Design Engineer assesses field reliability data and improves existing product designs as necessary
Assists in the evaluation of customer complaints on existing product designs.
Participates in the evaluation of non-conforming product to assist in the improvement of existing and new product designs.
The Design Engineer assists in the activities of analyzing repairs for improvement to new and existing devices.
Preferred Skills
Skilled in mechanical design and use of CAD to create detailed 3D models and engineering drawings.
Experience creating rapid prototypes and mock-ups and evaluating designs via testing and rigorous analysis.
Education and Experience
BS Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area).
3-5+ years of experience developing medical products.
Must be highly capable using Solid works.
Experience with metals or reusable surgical instruments is a plus.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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