Position Summary:
The Product Development Engineer is responsible for supporting the engineering and development of new and existing products. This role requires a solid understanding of manufacturing processes and the ability to align engineering efforts with business objectives. The ideal candidate will demonstrate professionalism, maturity, and discretion while working independently or collaboratively across departments.
Responsibilities:
- Lead new product development from concept to launch, including prototyping, testing, and technical documentation.
- Create detailed project timelines and ensure successful completion of product launches.
- Develop Master Validation Plans and Validation Protocols, including process, packaging, and sterilization validations.
- Collaborate with production, quality control, and ERP teams to prepare Bills of Materials and estimate product costs.
- Troubleshoot technical issues during prototyping, scale-up, and manufacturing.
- Write and revise batch records and standard operating procedures to support product introductions.
- Drive cross-functional collaboration to make data-driven decisions aligned with business goals.
- Assist with process optimization and scaling of existing products.
- Participate in special projects and provide solutions through designated channels.
Qualifications:
- B.S. in Biomedical Engineering, Material Science, Chemical Engineering, or a related field with 3+ years of engineering experience.
- Strong knowledge of collagen science and experience working in cross-functional teams (R&D, Quality, Manufacturing, Regulatory, etc.).
- Excellent organization and time management skills with the ability to prioritize in a fast-paced environment.
- Strong problem-solving abilities and proven success in managing projects.
- Effective verbal and written communication skills across all levels of the organization.
- Proficient in Microsoft Word, Excel, PowerPoint; experience with Minitab and Microsoft Projects.
- Familiarity with SolidWorks is a plus.
