R & D Engineer; Medical Device

Duration: 6-12+ months (Contract)

Pay range: $47-50/hr on W2

Job Description:

Key Responsibilities

• Lead end-to-end product development activities, including design, prototyping, testing, verification, and validation
  .
• Drive technical decisions and provide engineering expertise throughout the product lifecycle.
• Develop and review engineering specifications, design documents, and technical reports
  .
• Apply systematic problem-solving approaches to identify and resolve complex engineering challenges.
• Support design analysis and engineering evaluations throughout product development.
• Contribute to product lifecycle management activities from development through commercialization.

Cross-Functional Collaboration

• Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment throughout product development.
• Serve as a technical resource and mentor for junior engineers.
• Communicate complex technical concepts clearly to both technical and non-technical stakeholders.
• Participate in cross-functional design and technical reviews.
• Lead or contribute to multiple concurrent engineering and product development projects.
• Define project scope, timelines, milestones, and deliverables.
• Track project progress and proactively manage risks, dependencies, and technical challenges.
• Collaborate with cross-functional stakeholders to ensure projects remain aligned with established objectives and timelines.

Quality & Regulatory Compliance

• Ensure products meet applicable regulatory requirements, industry standards, and internal quality requirements
  .
• Support Design Verification and Design Validation (V&V) activities.
• Participate in formal design reviews, FMEAs, risk assessments, and change-control processes
  .
• Apply design-control principles throughout the product development lifecycle.
• Support compliance with applicable medical-device regulatory frameworks, including FDA 21 CFR Part 820 and ISO 13485
  , where applicable.
• Identify opportunities to improve products, processes, and engineering practices.
• Apply data-driven analysis to evaluate product and process performance and support engineering decisions.
• Utilize systematic problem-solving methodologies to address technical and product issues.
• Stay current with industry trends, emerging technologies, engineering practices, and applicable regulatory requirements.

Required Qualifications

Education

• Bachelor's degree (B.S.) in:
• Mechanical Engineering
• Electrical Engineering
• Biomedical Engineering
• or a related Engineering discipline.

Experience

• 5-8+ years of product engineering/product development experience
  .
• Experience with product development across design, testing, verification, and validation.
• Experience working in medical device or other regulated industry environments is preferred.
• Experience with Design Controls is preferred.

Required Technical Skills

• Product Lifecycle Management (PLM)
• Design Analysis
• Verification & Validation (V&V)
• V&V Testing
• Product Testing
• Design Controls
• FMEA
• Change Control
• Engineering Specifications
• Technical Documentation
• Design Reviews
• Data Analysis
• Systematic Problem Solving

Regulatory / Domain Knowledge

Preferred experience with:

• ISO 13485
• FDA 21 CFR Part 820
• Medical Device Design Controls
• Product Lifecycle Management (PLM)
• Quality and regulatory requirements applicable to medical devices
• Strong written and verbal communication skills
• Technical problem-solving
• Cross-functional collaboration
• Project management
• Analytical thinking
• Ability to manage multiple projects simultaneously
• Ability to communicate technical information to diverse audiences

Ideal Candidate Profile

The strongest candidates will have 5-8+ years of product engineering experience
, a B.S. in Engineering or a related field, and hands‑on experience with product development, design analysis, V&V testing, Design Controls, FMEA, risk assessments, and change control
, preferably within a medical-device or regulated industry environment
.