Job Description

Job Summary:

Our client is seeking a highly skilled Process Assembly Engineer to join the R&D manufacturing team in Covington, GA, supporting the development and scale-up of catheter products. A successful candidate will be responsible for designing, developing, validating, and optimizing catheter assembly processes to ensure high-quality, efficient, and compliant manufacturing from pilot builds through full-scale production.

This candidate would work directly with 5-10 other engineers in tandem with the entire R&D team who sits out of this facility. This is one of the fastest growing R&D teams in terms of product launches and the only one to have their products shown on TV commercials. Their main focus will be on technical product design elements, working with the R&D team on front end process development.

This role offers the opportunity to influence the design and manufacturability of life-saving catheter products from concept to commercialization.

Key Responsibilities:

Process Development & Optimization

• Develop and document assembly methods, including work instructions, process flow diagrams, and standard operating procedures.
• Conduct Design for Manufacturability (DFM) reviews to identify and address potential production challenges early in the design phase.

Validation & Scale-Up

• Lead equipment and process validation activities (IQ, OQ, PQ) in compliance with FDA and ISO 13485 requirements.
• Support pilot production runs, troubleshoot assembly issues, and refine processes based on performance data.

Equipment & Tooling

• Specify, source, and implement assembly equipment, fixtures, and tooling to support catheter production.
• Collaborate with tooling vendors to ensure equipment meets performance and regulatory specifications.

Quality & Compliance

• Ensure processes meet all BD quality standards and applicable regulatory requirements (FDA, ISO 13485).

Qualifications:

Education & Experience

• 3+ years of experience in medical device manufacturing or process engineering, preferably in catheter assembly or similar high-precision products.

Skills & Competencies

• Strong knowledge of assembly processes for small, intricate medical devices (adhesive bonding, thermal forming, tipping, joining, etc.).
• Familiarity with Good Manufacturing Practices (GMP), FDA 21 CFR Part 820, and ISO 13485.
• Proficiency in CAD software (SolidWorks preferred) for fixture and tooling design.
• Experience with statistical process control (SPC), root cause analysis, and Lean/Six Sigma methodologies.
• Excellent problem-solving skills, hands-on aptitude, and ability to work in a collaborative, fast-paced environment.

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