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Process Engineer

Biomerics
Winston Salem, NC
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 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 the 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 Description

The Process Engineer is responsible for supporting and improving existing products and manufacturing processes throughout their lifecycle. This role focuses on resolving product issues, implementing process improvements, ensuring regulatory compliance, and improving efficiency standards. The Process Engineer works cross-functionally with manufacturing, quality, supply chain, and design engineering teams to drive continuous improvement and product reliability.

Responsibilities

  • Provide engineering support for existing products to address quality, cost, and reliability concerns.
  • Lead root cause investigations and corrective/preventive actions (CAPA) for product or process issues.
  • Manage engineering change orders (ECOs), product updates, and documentation revisions.
  • Partner with manufacturing and quality to improve yield, reduce defects, and optimize production processes.
  • Support regulatory submissions, compliance requirements, and audits as needed.
  • Conduct testing and validation for product modifications, process improvements, and design updates.
  • Collaborate with R&D and design engineering to address customer feedback and performance issues.
  • Maintain product lifecycle management (PLM) systems and ensure proper documentation control.
  • Provide technical training and support to operations and customer service teams.

Requirements

  • Bachelor’s degree in Industrial, Mechanical, Biomedical, or related Engineering discipline.
  • 3–5 years of engineering experience in product development, process, or manufacturing support (medical device, aerospace, automotive, or similar regulated industry preferred).
  • Strong problem-solving and root cause analysis skills (e.g., 8D, DMAIC, FMEA).
  • Experience with CAD, product data management (PDM/PLM), and ERP systems.
  • Knowledge of regulatory and quality systems (ISO 13485, FDA QSR, ISO 9001, etc. if applicable).
  • Excellent communication, documentation, and cross-functional collaboration skills.
  • Ability to manage multiple projects and priorities in a fast-paced environment.
  • Minimum 6 Sigma Green Belt, Black Belt preferred

Preferred Skills

  • Experience with Lean manufacturing and Six Sigma tools.
  • Familiarity with reliability testing and risk management practices.
  • Knowledge of supplier qualification and component change management.
  • Hands-on troubleshooting and prototyping experience.
  • Experience with complaint handling and post-market surveillance.
  • Knowledge of statistical techniques and tools (DOE, SPC, Six Sigma).

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.

Biomerics does not accept non - solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.
Posted 2025-09-18

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