R&D Engineer

Summary:

Apply engineering expertise to design, develop and test implantable medical devices, including cardiac stimulation systems, neuromodulation devices including leads. Support product verification and validation activities to ensure robust, compliant designs aligned with the company’s strategic objectives. Collaborate cross-functionally on product design and development, process optimization, and verification and validation testing to enable successful product transfer to manufacturing.

Principal Tasks & Responsibilities:

• Prototype, assemble, and iterate design concepts using rapid-cycle feedback.
• Execute design verification and validation testing, test method development/validation and process development/validation with minimal supervision.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, protocols, and reports to support design control activities.
• Accurately document data and prepare written reports for inclusion in the Design History File.
• Participate in and contribute to periodic team updates and actively support any project change requests.
• Drive root-cause analysis and continuous improvement of design and build processes.
• Troubleshoot assembly process issues and train R&D technicians on product assembly.
• Contribute to IP generation, patent filings and technical publications.

Qualifications:

Education:

• BS in Mechanical Engineering required. PhD degree is a plus.

Experience required:

• With implantable medical devices, including pacemakers and/or leads, cardiac pacing systems or electrical stimulation devices
• 5+ years of experience in medical device product development
• Experience supporting and participating in preclinical animal studies
• Familiar with neurovasculature applications and regulatory (DV) requirements

Skills:

• Strong interpersonal, organizational and communication skills (written and oral)
• Hands-on, adaptable team player with positive, goal-focused mindset
• Demonstrated ability to deliver results in a dynamic, deadline-driven environment
• Statistical analysis (sample plans, reliability calculations) knowledge
• High proficiency in SolidWorks required
• Proficient with Microsoft Office applications