Project Engineer II
Listed on 2025-12-24
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Engineering
Biomedical Engineer, Quality Engineering
Apply for the Project Engineer II role at Biomerics
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Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
Job TypeFull‑time
Job SummaryAs a Project Engineer II, you will take ownership of medium‑scale projects and make significant contributions to product and process development. You will work under moderate supervision and help drive technical solutions from concept through commercialization.
Job Responsibilities- Lead technical execution of projects, ensuring timelines, budgets, and quality requirements are met.
- Collaborate with internal teams and external customers on design and manufacturing improvements.
- Conduct root cause analysis and implement corrective actions.
- Develop and execute validation protocols (IQ/OQ/PQ) and engineering studies.
- Prepare and maintain detailed documentation, including DHFs, DMRs, and process instructions.
- Mentor junior engineers and provide technical guidance.
- Bachelor’s degree in Engineering;
Master’s preferred.
- 3–5 years of experience in project engineering or product development, preferably in medical devices.
- Strong knowledge of ISO 13485 and risk management (ISO 14971).
- Experience in product lifecycle management and process validation.
- Strong problem‑solving, interpersonal, and communication skills.
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