Senior Mechanical Engineer - R&D

Responsibilities

• Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
• Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
• Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
• Create 3D models, engineering drawings and bill of materials
• Create comprehensive work instructions and manufacturing SOP’s
• Work with quality to resolve any issues with components or processes
• Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
• Comply with company’s policies and guidelines regarding quality and regulatory

Qualifications

• Bachelor's Degree in Mechanical Engineering
• 5 plus years hands-on experience in a design environment
• Experience with creating engineering drawings, BOMs, and product specifications
• In-depth experience with complex mechanical systems that interact with biology
• Prior experience in a medical device company
• Experience with design control process for medical devices and implementation of product in to manufacturing
• Working knowledge of FDA regulations and ISO, cGMP, QMS standards
• Good understanding of DFM and lean manufacturing
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Knowledge and/or hands-on experience with machine shop tools
• Proficiency with SolidWorks required
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• Knowledge /experience with plastic injection molding
• Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering