Job Title: Senior Manufacturing Engineer
Location: Lindon, UT
Company Overview
BirdieRP is an ISO 13485–certified medical device manufacturer specializing in precision injection molding and assembly of Class I and II medical products. We are committed to quality, compliance, and continuous improvement in every aspect of our operations.
Position Summary
We are seeking an experienced Senior Manufacturing Engineer to support and lead engineering activities within our medical device injection molding facility. This role is responsible for optimizing injection molding processes, supporting production, leading validation activities, and ensuring compliance with medical device quality standards.
The ideal candidate has strong technical expertise in injection molding of medical-grade components, deep understanding of molded part design and manufacturability, and hands-on experience with validation and regulated production environments.
Key Responsibilities
- Lead and support injection molding process development, optimization, and troubleshooting.
- Drive continuous improvement initiatives to improve quality, reduce scrap, and increase efficiency.
- Develop, document, and maintain robust molding processes and work instructions.
- Lead validation activities including IQ, OQ, PQ, and process capability studies.
- Support new product introductions (NPI), including tooling reviews and manufacturability assessments.
- Collaborate with Quality, Production, and Tooling teams to ensure compliance with FDA, ISO 13485, and GMP requirements.
- Analyze and resolve molding defects (short shots, flash, warp, sink, splay, etc.).
- Support root cause investigations and corrective/preventive actions (CAPA).
- Evaluate and implement automation and secondary operations as needed.
- Monitor and improve OEE, cycle times, and scrap rates.
- Mentor junior engineers and technical staff.
Qualifications
- Bachelor’s degree in Engineering (Mechanical, Manufacturing, Plastics, or related field).
- 7+ years of experience in injection molding manufacturing, preferably in medical devices.
- Strong understanding of injection molded part design, materials (resins), tooling, and DFM principles.
- Hands-on experience with process validation (IQ/OQ/PQ) in regulated environments.
- Experience with scientific molding principles preferred.
- Knowledge of FDA regulations, ISO 13485, GMP, and quality systems.
- Proficiency in statistical analysis, DOE, and process capability studies.
- Strong troubleshooting and problem-solving skills.
- Excellent communication and cross-functional collaboration skills.
Preferred Qualifications
- RJG certification or scientific molding training.
- Experience with cleanroom molding environments.
- Experience with automation and robotics integration.
- Six Sigma or Lean certification.
Key Competencies
- Advanced troubleshooting and analytical thinking.
- Data-driven decision-making.
- Technical leadership and mentorship.
- Strong documentation and regulatory compliance discipline.
- Ability to manage multiple projects in a high-volume manufacturing environment.