What are the responsibilities and job description for the Product Innovation Engineer (62527) position at ASP Global, LLC?
At ASP Global, we don't just source and deliver healthcare products—we develop innovative solutions that help healthcare providers improve patient outcomes, streamline care delivery, and solve real-world clinical challenges. As a trusted partner to leading health systems across the country, we're looking for an innovative engineer who is passionate about transforming customer insights into meaningful healthcare products.
If you're energized by solving complex problems, collaborating directly with clinicians, and bringing new medical device concepts to life, we invite you to explore our Product Innovation Engineer opportunity.
What You'll Do
As our R&D Product Innovation Engineer, you will lead early-stage product innovation efforts from concept through Design Freeze by:
- Partnering directly with clinicians, healthcare providers, and stakeholders to uncover unmet clinical and market needs.
- Leading Voice of Customer (VoC) activities, including interviews, field observations, and user research.
- Translating customer insights into measurable user needs and engineering requirements.
- Generating innovative product concepts and evaluating technical feasibility, usability, regulatory considerations, and business impact.
- Developing prototypes and validating concepts through testing and user feedback.
- Collaborating cross-functionally with Quality, Regulatory, Clinical, Manufacturing, and Product Development teams.
- Driving concept refinement and design iterations through Design Freeze.
- Supporting risk management activities and maintaining design traceability throughout development.
- Ensuring concepts align with regulatory requirements, design controls, and production capabilities.
What We're Looking For
The ideal candidate will bring:
Education
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
Experience
- 3–7 years of medical device product development experience.
- Hands-on experience with early-stage innovation, concept development, and product design.
- Experience conducting Voice of Customer activities and translating findings into product requirements.
- Working knowledge of Design Controls and product development within a regulated environment.
Skills & Expertise
- Ability to transform ambiguous clinical needs into structured, testable engineering solutions.
- Strong concept generation, prototyping, and problem-solving capabilities.
- Experience balancing technical feasibility, customer needs, and business objectives.
- Excellent collaboration and communication skills across cross-functional teams.
- Ability to thrive in fast-paced, evolving development environments.
Preferred Qualifications
- Knowledge of ISO 13485 and ISO 14971.
- Experience with human factors and usability engineering.
- Familiarity with FDA 510(k), EU MDR, and regulatory submission processes.
- Experience working directly with healthcare professionals or within clinical environments.
- Exposure to intellectual property development, invention disclosures, or patents.
Why ASP Global?
ASP Global is committed to developing custom, compliant healthcare products that help providers deliver exceptional patient care. Our product development teams work directly with healthcare systems to identify opportunities for innovation and create solutions that make a measurable impact across the healthcare continuum. This is your opportunity to help shape the next generation of healthcare products while working alongside industry experts in a growing, innovation-focused organization.