Product Development Engineer
On-site · Apex, North Carolina, United States
Job Summary
Develop and validate custom device components and assemblies, including ideation, prototyping, process optimization, qualification, and quality compliance. Partner with senior engineers to deliver product development processes, engage with internal stakeholders, and collaborate with business development, vendors, and clients. Responsibilities include supporting multiple projects through various stages of the product life cycle, communicating development status to internal leaders, assisting in design/manufacturing for scalable production, identifying tooling and equipment needs, transitioning processes from development to commercial groups, and maintaining comprehensive development documentation per quality standards. Qualifications emphasize a Bachelor’s degree in engineering, 1–2 years of manufacturing/product development experience, ISO 9001/13485 knowledge, FDA regulations awareness, ability to translate client needs into engineering requirements, strong teamwork, analytical/problem-solving skills, and proficiency with technical writing and tools such as Minitab and Microsoft Office.
Required Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline
- 1-2 years of industry-related experience in a manufacturing or product development environment
- Familiar with ISO 9001, and 13485 Quality Management Standards; knowledge of FDA Regulations
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.