Project Engineer II
3 days ago
Description
Company Overview
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.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
Job Summary
As 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.
Requirements
Education / Certifications
- Bachelor's degree in Engineering; Master's preferred.
Qualifications
- 3–5 years of experience in project engineering or product development, preferably in medical devices.
- Strong knowledge of ISO 13485 and risk management (ISO
- Experience in product lifecycle management and process validation.
- Strong problem-solving, interpersonal, and communication skills.
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