NEWPosted 4 hours ago
Job ID: JOB_ID_3593
Job Summary:
We are seeking a Process Engineer with experience in product formulation, biomaterials, and medical device process development. The candidate will lead process design, scale-up, and product characterization while collaborating with suppliers, CDMOs, and manufacturing teams to deliver scalable and high-quality solutions.
Key Responsibilities:
- Lead process design and development from modeling through pilot scale and qualification.
- Collaborate with external suppliers, CDMOs, and manufacturing facilities to develop and optimize production processes.
- Drive process and product characterization to meet scale-up metrics such as cost, quality, and scrap reduction.
- Work with raw material suppliers to evaluate and iterate materials aligned with product design requirements.
- Execute learning plans and technical studies in collaboration with supply chain teams.
- Conduct in-vitro and ex-vivo testing of prototypes.
- Develop protocols, technical reports, and documentation supporting product development.
- Apply analytical problem-solving tools and Design of Experiments (DOE) to improve process performance.
- Mentor and support junior engineers in process design and development.
Required Technical Skills:
- Product formulation and launch experience.
- Biomaterials or material development.
- Medical device and combination product knowledge.
- Familiarity with PMA regulatory pathways.
- Design of Experiments (DOE).
- Analytical problem-solving tools.
- Protocol development and technical documentation.
- In-vitro / ex-vivo characterization.
- Process scale-up and pilot manufacturing.
- Cross-functional collaboration.
Compensation & Location
Salary: $90,000 – $130,000 per year
Location: Raritan, NJ
Recruiter / Company – Contact Information
Email: endra@quantumworldit.com
Recruiter Notice:
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