Product Innovation Engineer

Product Innovation Engineer

AUSTELL, GA 30168

Position Type Full Time Education Level 4 Year Degree Travel Percentage Up to 25%

Role

Summary:

The R&D New Product Innovation Engineer is responsible for driving early-stage product development from concept generation through Design Freeze for medical devices. This role leads Voice of Customer (VoC) activities, translates user needs into defined product requirements, and ensures concepts are feasible, compliant, and aligned with business objectives. The engineer collaborates cross-functionally to develop innovative solutions while maintaining adherence to design control and regulatory expectations.

• Lead Voice of Customer (VoC) activities including interviews, field observations, surveys, and stakeholder engagement to identify unmet clinical and market needs.
• Translate VoC insights into well-defined, measurable User Needs and Design Inputs aligned with intended use and regulatory requirements.
• Generate and evaluate new product concepts, including feasibility assessments, risk considerations, and preliminary design approaches.
• Develop concept prototypes (breadboard, alpha models, or simulations) to validate functionality and user interaction with internal or external resources.
• Drive structured concept evaluation through defined criteria (technical feasibility, usability, regulatory pathway, cost targets).
• Establish and maintain traceability from User Needs to Design Inputs and early Design Outputs during concept development.
• Collaborate with Quality, Regulatory, Clinical, and Manufacturing teams to ensure concepts align with applicable standards, risk management expectations, and intended production capabilities.
• Support development of preliminary risk management documentation (e.g., hazard analysis, use-related risk analysis) to inform design decisions.
• Lead progression of selected concepts through feasibility and design iterations to achieve Design Freeze.
• Document design decisions, concepts, and supporting rationale in accordance with Design Control and DHF requirements.
• Ensure design outputs at Design Freeze are complete, approved, and aligned with defined inputs and intended use.

Required

Education:

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related engineering discipline.

Required Experience:

• 3–7 years of experience in medical device product development, with emphasis on early-stage innovation or concept development.
• Experience applying Design Controls (e.g., user needs, design inputs/outputs, traceability) in a regulated environment.
• Experience conducting Voice of Customer or user research activities and translating findings into product requirements.

Required

Skills and Abilities:

• Ability to manage VoC and to develop concepts from clinician discussions.
• Ability to translate ambiguous, qualitative inputs into structured, testable engineering requirements.
• Experience with concept generation techniques and rapid prototyping methods.
• Strong analytical and problem-solving skills with a focus on innovation and feasibility.
• Ability to manage multiple concepts and prioritize based on business and technical criteria.
• Proficiency with documentation tools and structured templates (e.g., requirements documents, traceability matrices).
• Self-driven with ability to operate in early-stage, less-defined development environments.

Preferred Qualifications:

• Strong understanding of medical device development processes, including Design Controls and risk management (ISO 13485, ISO 14971).
• Facilitate cross-functional design reviews to assess risks, requirements alignment, and readiness for advancement.
• Experience with human factors/usability engineering in medical devices.
• Familiarity with regulatory submission requirements (e.g., FDA 510(k), EU MDR).
• Experience in clinical environments or working directly with healthcare professionals.
• Exposure to IP generation (e.g., invention disclosures, patents).