RD Engineer

Gateway Recruiting; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Gateway Recruiting is seeking an experienced Mechanical Engineer to design, develop, and test implantable medical devices, including cardiac stimulation systems and leads. You will collaborate across functions to advance product verification and validation, ensuring designs meet regulatory and company goals.

You will prototype concepts, perform V&V testing, document data for the Design History File, and contribute to process improvements and IP generation.

Qualifications

• Education: BS in Mechanical Engineering required, PhD a plus.
• Experience: 5+ years in medical device product development, including implantables.
• Experience: preclinical animal studies.
• Regulatory: familiarity with regulatory DV requirements.

Responsibilities

• Prototype, assemble, and iterate design concepts using rapid-cycle feedback.
• Execute design verification and validation testing, test method development/validation and process validation.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, protocols, and reports for DHF.
• Accurately document data and prepare written reports for the Design History File.
• Participate in and contribute to periodic team updates and 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.

Skills

SolidWorks

MS Office

Interpersonal skills

Written & oral communication

Statistical analysis

Education

BS in Mechanical Engineering

PhD degree a plus

Job description

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